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Adverse Event Report

DENVER BIOMATERIALS, INC. PLEURX PLEURAL CATHETER IMPLANTED PLEURAL CATHETER FOR PLEURAL EFFUSION   back to search results
Catalog Number 50-7000
Event Date 04/18/1998
Event Type  Malfunction   Patient Outcome  Other;
Event Description

Implanted catheter with external valve in place more than 2 mos. Pleural effusion had just been drained using supplies provided for that purpose. When nurse attempted to remove access dilator, the entire valve assembly fell out of the catheter. Nurse immediately clamped the catheter. Physician carried out repair the next day using a valve assembly from a separate pleurx catheter. Pt did not develop any complications from either the initial valve loss or the repair procedure.

 
Manufacturer Narrative

Bulk of investigation through interview with reporting physician. Current work in progress (100 units) visually examined for secure placement of valve assembly. All acceptable. As described, event due to either insufficient friction between valve and catheter or too tight a fit between access dilator and valve housing. Improper handling during repeated drainage procedures may have significantly contributed to the event. In particular, holding the catheter, rather than the valve housing during the procedures would have exerted a repeated pull force that could have loosened the valve housing. The instructions for use specify holding the valve housing while attaching the access dilator.

 
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Brand NamePLEURX PLEURAL CATHETER
Type of DeviceIMPLANTED PLEURAL CATHETER FOR PLEURAL EFFUSION
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
DENVER BIOMATERIALS, INC.
14998 w. 6th ave., bldg. e700
golden CO 80401
Manufacturer (Section D)
DENVER BIOMATERIALS, INC.
14998 w. 6th ave., bldg. e700
golden CO 80401
Manufacturer (Section G)
CARDINAL HEALTH
14998 west 6th ave., bldg.e700
golden CO 80401
Device Event Key164315
MDR Report Key168917
Event Key158724
Report Number1717671-1998-00001
Device Sequence Number1
Product CodeKPM
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 05/15/1998
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/15/1998
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date11/01/2003
Device Catalogue Number50-7000
Device LOT Number219650 7/00
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/18/1998
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device? No Answer Provided
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 05/15/1998 Patient Sequence Number: 1
#TreatmentTreatment Date
1,REGULAR USE OF PLEURX DRAINAGE KITS SINCE TIME OF,
2,IMPLANT. PROBABLY OTHERS FOR TREATMENT OF PRIMARY,
3,DISEASE
TYPES UNK.,

Database last updated on January 30, 2009

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