BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZ SUPER STIFF GUIDEWIRE

    MDR report key: 2103653 · Received May 26, 2011

    Report

    Report Number
    2134265-2011-02127
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    April 29, 2011
    Report Date
    April 29, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K843012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE REMOVAL DIFFICULTY OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 80% STENOSED DENOVO LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY (SFA). A .035 NON BSC SUPPORT CATHETER AND A AMPLATZ SUPER STIFF GUIDE WIRE WERE ADVANCED TO THE TARGET LESION. AN ATTEMPT TO CROSS FROM THE RIGHT COMMON ILIAC BIFURCATION INTO THE LEFT COMMON ILIAC WITH A 6FR X 10CM NON BSC INTRODUCER SHEATH WAS UNSUCCESSFUL. WHILE REPLACING THE NON BSC INTRODUCER SHEATH, THE PHYSICIAN TORQUED THE .035 NON BSC SUPPORT CATHETER AND THE AMPLATZ GUIDE WIRE AND THE DEVICES "LOCKED" TOGETHER. DURING WITHDRAWAL THE NON BSC SUPPORT CATHETER BROKE IN HALF AND THE DISTAL PORTION OF THE DEVICE REMAINED AFFIXED TO THE AMPLATZ GUIDE WIRE. THE DEVICES MIGRATED TO THE COMMON FEMORAL ARTERY. THE PATIENT WAS TAKEN TO SURGERY. A CUT DOWN WAS PERFORMED ON THE COMMON FEMORAL ARTERY TO OPEN THE VESSEL. WIRE CUTTERS WERE USED TO CLIP THE DISTAL END OF THE AMPLATZ GUIDE WIRE AND THE BROKEN DISTAL PORTION OF THE NON BSC SUPPORT CATHETER. THE DEVICES WERE REMOVED VIA THE 6FR X 10CM NON BSC INTRODUCER SHEATH. NO FURTHER INTERVENTION WAS PERFORMED DUE TO THE TORTUOUS VESSELS AND THE AMOUNT OF CONTRAST THAT HAD BEEN ADMINISTERED TO THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZ SUPER STIFF GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA M001465251 14094011

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention .035 QUICKCROSS CATHETER| PINACCLE DESTINATION SHEATH 6FX10CM