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Adverse Event Report

CORDIS INFINITI ANGIOGRAPHIC CATHETER 4F (1.35MM) 110CM .038' PIG   back to search results
Model Number 0502185
Event Date 08/02/2002
Patient Outcome  Other;
Event Description

Angiographic catheter tip. During a left heart catheterization with a 4 french pigtail, the cardiologist introduced the catheter through the sheath over the wire. The wire would not come out of the end hole of the catheter. The physician pulled the catheter and the wire out of the sheath. The tip of the pigtail catheter broke off during withdrawal. The sheath was removed and pressure was applied to the site of entry until hemostasis was achieved. The patient had no adverse effects following this incident. The sheath was examined, but no pieces of the catheter were found. The tip of the pigtail was located under fluoroscopy in the area of the right femoral artery. After several attempts, the radiologist was able to retrieve the tip using "balkin up and over-the-sheath" method and "cook intravascular forceps". The site does not have any history of this type of device failure and has not experienced problems with other catheters of the same manufacturer and lot number. The physician had not experienced any problems during the procedure prior to this incident and has had training and experience in using this device. This device was used appropriately for this procedure. The site has made a technical change to the procedure following this event involving the need to be sure the guidewire is placed (advanced) all the way to the tip of the catheter before attempting to cross the aortic valve. Device failed (e. G. Broke, couldn't get it to work or stopped working).

 
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Brand NameINFINITI
Type of DeviceANGIOGRAPHIC CATHETER 4F (1.35MM) 110CM .038' PIG
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
CORDIS
14201 mw 60th avenue
miami lakes FL 33014
Manufacturer (Section D)
CORDIS
14201 mw 60th avenue
miami lakes FL 33014
Device Event Key426650
MDR Report Key437715
Event Key414249
Report Number437715
Device Sequence Number1
Product CodeDQO
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 08/19/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/15/2003
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date04/01/2005
Device MODEL Number0502185
Device Catalogue Number538-4505
Device LOT NumberX0502185
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/05/2002
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/19/2002
Device Ageunknown
Event Location Hospital
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided

Database last updated on February 28, 2009

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