FDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website

FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH U.S. Food and Drug Administration Center for Devices and Radiological Health [Skip navigation]
horizonal rule

Super Search
510(k) | Registration & Listing | Adverse Events | PMA | Classification | CLIA
CFR Title 21 | Advisory Committees | Assembler | Recalls | Guidance | Standards
 

 

Adverse Event Report

BARD ACCESS SYSTEMS BROVIAC CATHETER   back to search results
Model Number NO NOT KNOW
Event Date 12/01/2001
Patient Outcome  Other;
Event Description

This pt had a 2. 7 french broviac placed in 2001. It was used for infusion of medication. The catheter was initially inserted into the saphenous vein which was then checked intra-operatively using fluoroscopy to confirm placement. Seven months later, the pt required placement of a feeding tube, and it was felt the broviac was no longer needed. The nurses had been able to infuse medicine through the broviac, but had not been able to draw from it. The broviac was removed by left saphenous vein cut-down. On 4/2002 the pt had a vcug [voiding cystourethrogram] to evaluate for reflux, and a fragment of the [broviac] catheter was noted to be in the inferior vena cava and left common iliac. [the pt has experienced no sequela from this incident. It is not known why the device was not examined when removed other than the physician may not have known it was broken until the fragment was found. The life expectancy for this device and how long this catheter should remain in place are not known. According to the facility's database, only one other report has been made regarding a broviac catheter breaking during removal. It is not known if the catheter had actually broken prior to removal or upon removal. The other devices within the same lot number have not been checked for signs of poor production. It is not known if the labeling instructions or warnings for this device say anything specific about using it for the duration it was in use for in this situation. The facility is not considering any procedural changes at this time based on this incident. Staff do report they are able to draw blood from broviac catheters under normal circumstances. The radiology report gives the exact location of the fragment as extending from the right upper quadant to the region of the left common iliac vein. The tip of the fragment projects over the left mid portion of the sacroiliac joint. It further states the fragment is approximately 11 cm in length and the proximal portion appears unchanged in comparison to a previous x-ray. The catheter initially was inserted into the saphenous vein and it was checked intra-operatively using fluoroscopy. It is not known what procedure was used to remove the fragment. The fragment was not retained or given to the mfr at the time of removal although the facility is continuing to educate staff on the importance of saving such devices. Device usage problem: device failed (e. G. Broke, couldn't get it to work or stopped working).

 
Search Alerts/Recalls

  new search  |  submit an adverse event report

Type of DeviceBROVIAC CATHETER
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
BARD ACCESS SYSTEMS
5425 west amelia earhart dr.
salt lake city UT 84116
Manufacturer (Section D)
BARD
5425 west amelia earhart drive
salt lake city UT 84116
Device Event Key417412
MDR Report Key428387
Event Key405269
Report Number428387
Device Sequence Number1
Product CodeDQO
Report Source User Facility
Reporter Occupation Invalid Data
Type of Report Initial
Report Date 08/01/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/12/2002
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Invalid Data
Device MODEL NumberNO NOT KNOW
Device Catalogue NumberNO NOT KNOW
Device LOT NumberNO NOT KNOW
OTHER Device ID NumberNO NOT KNOW
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? Yes
Event Location Invalid Data
Is the Device an Implant? Yes
Is this an Explanted Device?

Patient TREATMENT DATA
Date Received: 11/12/2002 Patient Sequence Number: 1
#TreatmentTreatment Date
1,NOT KNOWN.,

Database last updated on February 28, 2009

horizonal rule

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH