BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASAHI PROWATER PTCA GUIDE WIRE

    MDR report key: 3691441 · Received March 20, 2014

    Report

    Report Number
    3003775027-2014-00021
    Event Type
    Malfunction
    Date Received
    March 20, 2014
    Date of Event
    February 6, 2014
    Report Date
    February 24, 2014
    Manufacturer
    AV-ASAHI
    Product Code
    DQX
    PMA / PMN Number
    K022762
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS REPORTED TO BE DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE DEVICE IS MANUFACTURED BY ASAHI INTECC. CO. LTD. MEDICAL DIVISION; HOWEVER, (B)(4) DISTRIBUTES THE DEVICE AND IS RESPONSIBLE FOR MDR REPORTING.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS WAS PERFORMED BY ASAHI INTECC. CO. LTD: WITH THE PROVIDED INFORMATION, WE COULD NOT IDENTIFY THE CAUSE AND CIRCUMSTANCE OF THE REPORTED EVENT. SINCE ALL THE SHIPPED PRODUCTS ARE INSPECTED IN THE PRODUCTION PROCESS FOR MEETING THE PRODUCT SPECIFICATIONS AND RELEASE CRITERIA, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. WARNING SECTION OF THE INSTRUCTIONS FOR USE (IFU) DESCRIBES: IF ANY RESISTANCE IS FELT DUE TO SPASM OR THE GUIDEWIRE BEING BENT OR TRAPPED WHILE OPERATING THE GUIDE WIRE IN THE BLOOD VESSEL OR REMOVING IT, DO NOT MOVE OR TORQUE THE GUIDE WIRE. STOP THE PROCEDURE. DETERMINE THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY AND TAKE APPROPRIATE REMEDIAL ACTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE NON-ABBOTT LASER CATHETER COULD NOT BE ADVANCED OVER THE PROWATER GUIDE WIRE DUE TO RESISTANCE WITH THE CATHETER; POSSIBLE RESISTANCE UPON REMOVAL. ANGIOPLASTY OF THE REMAINING VESSEL WHICH WAS NOT ATHERECTOMIZED WAS COMPLETED WITHOUT REPORTED ISSUE. TWO STENTS WERE PLACED IN THE SUPERFICIAL FEMORAL ARTERY. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166017 ASAHI PROWATER PTCA GUIDE WIRE GUIDE WIRE DQX AV-ASAHI

    Patients

    Seq Age Sex Outcome Treatment
    1 SPECTRANETICS TURBO-TANDEM LASER CATHETER