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Adverse Event Report

C.R. BARD, BPT DV TRU-TRAC DILATATION CATH PTA CATHETER   back to search results
Catalog Number 0058564
Device Problems Removal difficulties; Device, incorrect care/use of
Event Date 09/15/1999
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

It was reported the catheter couldn't be removed through a 7fr sheath post stent dilation. The procedure was a left to right iliac-over bifurcation-post stent dilation. The wire wasn't in place when the ball, deflated & when attempting to remove the cath through the sheath. The entire system was removed as a single unit. Another of the same make was used to complete the case.

 
Manufacturer Narrative

H6, method: assigned as the sample; wasn't returned for evaluation. Conclusion: was assigned as the product was reportedly used up.

 
Search Alerts/Recalls

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Brand NameTRU-TRAC DILATATION CATH
Type of DevicePTA CATHETER
Baseline Brand NameBARD TRUTRAC PTA BALLOON DILATATION CATHETER
Baseline Generic NameVESSEL DILATOR
Baseline Catalogue Number0058564
Baseline Device FamilyANGIOPLASTY CATHETERS
Baseline Device 510(K) NumberK830608
Baseline Device PMA Number
Baseline Shelf Life Information No
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Date First Marketed01/01/1986
Manufacturer (Section F)
C.R. BARD, BPT DV
13183 harland dr. ne
covington GA 30014
Manufacturer (Section D)
C.R. BARD, BPT DV
13183 harland dr. ne
covington GA 30014
Manufacturer (Section G)
VAS-CATH
2380 teldo street
mississauga, ont
CANADA L5A 3V3
Manufacturer Contact
cindy luttrell
13183 harland dr. ne
covington , GA 30014
(770) 385 -2337
Device Event Key237466
MDR Report Key245108
Event Key229936
Report Number1058665-1999-00046
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 09/17/1999
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/15/1999
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number0058564
Device LOT Number44GIA026
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Age14 mo
Event Location Hospital
Date Manufacturer Received09/17/1999
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/01/1998
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on February 28, 2009

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