BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTEUS PTA CATHETER W/ EMBOLIC CAP

    MDR report key: 3150424 · Received March 22, 2013

    Report

    Report Number
    3009106639-2013-00003
    Event Type
    Injury
    Date Received
    March 22, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 21, 2013
    Manufacturer
    ANGIOSLIDE LTD.
    Product Code
    LIT
    PMA / PMN Number
    K090364
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: FAILURE INVESTIGATION IS NOT YET COMPLETE AND THEREFORE, NO CONCLUSION CAN BE DRAWN AT THIS TIME. CONCLUSION: NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    TREATMENT OF LEFT SFA WITH 5X100 BALLOON ACCESSED WITH 0.035" GUIDE WIRE (ROSEN) AND 7FR SHEATH. DEVICE PREPARED PER IFU AND INSERTED INTO PT. INFLATED TO 8ATM FOR 1 MINUTE THEN TAKEN DOWN TO 2ATM AND CAPTURE PROCESS INITIATED. ON FLUORO IT WAS EVIDENT THAT THE BALLOON DID NOT FOLD PROPERLY. THE DR PROCEEDED TO WITHDRAW THE BALLOON BUT IT WOULD NOT MOVE. CORRECTIVE MANEUVER WAS INITIATED AS DIRECTED IN THE IFU AND THE DEVICE MOVED BUT WOULD NOT ENTER THE SHEATH. A SECOND CORRECTIVE MANEUVER WAS EMPLOYED (ADVANCING THE HANDLE AND DEFLATING THE BALLOON) AND THE DEVICE WAS EASILY REMOVED FROM THE PT. AFTER REMOVAL A VESSEL DISSECTION WAS NOTED AND THE PHYSICIAN PLACED A STENT IN THE SFA. IT IS BELIEVED THE VESSEL DISSECTION OCCURRED AS A RESULT OF PULLING ON THE BALLOON AND IT NOT BEING ABLE TO MOVE AS MENTIONED ABOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120945 PROTEUS PTA CATHETER W/ EMBOLIC CAP CATHETER, ANGIOGRAPLASTY, PERIPHERAL, TRAN LIT ANGIOSLIDE LTD. FD1036-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention