BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONQUEST PTA BALLOON DILATATION CATHETER

    MDR report key: 3854892 · Received May 27, 2014

    Report

    Report Number
    2020394-2014-00238
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 30, 2014
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K083657
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO ENSURE COMPLIANCE TO 21 CFR 803.50 A RETROSPECTIVE REVIEW OF THIS FILE WAS CONDUCTED TO DETERMINE IF GOOD FAITH EFFORTS WERE MADE TO OBTAIN THE REQUIRED INFORMATION AND/OR AN EXPLANATION OF WHY ANY REQUIRED INFORMATION WAS NOT PROVIDED. MULTIPLE FOLLOW UP ATTEMPTS WERE MADE WITH THE FACILITY TO OBTAIN ANY INFORMATION PERTAINING TO THE PATIENT, PRODUCT, AND/OR PROCEDURAL DETAILS (E.G. DATE OF THE EVENT, RELEVANT TEST DATA, RELEVANT HISTORY, LOT #, CATALOG #, IMPLANT AND/OR EXPLANTED DATES, AND CONCOMITANT PRODUCT(S) OR THERAPY) THAT WERE NOT PREVIOUSLY OBTAINED DURING THE INITIAL INVESTIGATION. THE FACILITY WAS ABLE TO PROVIDE NEW PATIENT INFORMATION, WHICH WAS UPDATED IN THE APPROPRIATE SECTIONS. THE FILE WAS UPDATED WITH AN EXPIRATION DATE THAT WAS NOT PREVIOUSLY REPORTED.

    Additional Manufacturer Narrative · 1

    A COMPLETE MANUFACTURING REVIEW WAS PERFORMED AND THERE WAS NOT EVIDENCE THAT THE FAILURE MODE REPORTED IN THIS COMPLAINT WAS CAUSED BY THE MANUFACTURING PROCESS. THE LOT MET ALL RELEASE CRITERIA. THE DEVICE WAS RETURNED FOR EVALUATION. THE PARTIAL CONQUEST PTA CATHETER SEGMENT CONTAINED THE BALLOON AND MEASURED APPROXIMATELY 23.3CM IN LENGTH. THE EDGES OF THE PROXIMAL POINT OF THE DETACHMENT WERE EXAMINED AND SIGNS OF STRETCHING WERE OBSERVED, LIKELY INDICATING THAT EXCESSIVE FORCE CONTRIBUTED TO THE DETACHMENT. THE INVESTIGATION IS CONFIRMED FOR SHEATH RETRACTION ISSUES DUE TO THE CONDITION IN WHICH THE SAMPLE WAS RECEIVED (I.E. PROLAPSED BALLOON MATERIAL AT DISTAL TIP). THE INVESTIGATION IS CONFIRMED FOR A CIRCUMFERENTIAL RUPTURE AT THE PROXIMAL CONE OF THE BALLOON. THE INVESTIGATION IS ALSO CONFIRMED FOR A CATHETER DETACHMENT, AS A CATHETER SEGMENT CONTAINING THE BALLOON WAS RETURNED DETACHED FROM THE CATHETER SEGMENT CONTAINING THE HUB. PER THE COMPLAINT COMMENTS, THE BALLOON WAS INFLATED NEAR A STENT. IT IS UNKNOWN IF THE STENT CONTRIBUTED TO THE BALLOON RUPTURE. IT IS LIKELY THAT THE BALLOON RUPTURE CONTRIBUTED TO THE BALLOON GETTING CAUGHT ON THE NEARBY STENT DURING RETRACTION AND DIFFICULTIES RETRACTING THE BALLOON THROUGH THE INTRODUCER SHEATH. HOWEVER, BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VASCULAR STENT DEPLOYMENT PROCEDURE, POST ANGIOPLASTY THE PTA BALLOON RUPTURED AT 20ATM AND DISPLACED A VASCULAR STENT AS THE BALLOON WAS BEING RETRACTED. AFTER SEVERAL ATTEMPTS AT REMOVAL, THE BALLOON WAS FULLY RETRACTED WITHOUT FURTHER INCIDENT. AN ADDITIONAL VASCULAR STENT WAS DEPLOYED. THERE WAS NO ADVERSE CLINICAL EVENT TO THE PATIENT AND THE CEPHALIC VEIN WAS REPORTED TO BE PATIENT WITH GOOD BLOOD FLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311834 CONQUEST PTA BALLOON DILATATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. REYB2251

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention