BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASAHI PROWATER PTCA GUIDE WIRE

    MDR report key: 2923091 · Received January 18, 2013

    Report

    Report Number
    3003775027-2013-00005
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 27, 2012
    Manufacturer
    AV-ASAHI
    Product Code
    DQX
    PMA / PMN Number
    K031277
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 IS MANUFACTURED BY ASAHI (B)(4); HOWEVER, ABBOTT VASCULAR DISTRIBUTES THE DEVICE AND IS RESPONSIBLE FOR MDR REPORTING. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE ANALYSIS WAS PERFORMED BY ASAHI (B)(4): INSPECTION OF RETURNED PROWATER GUIDE WIRE REVEALED SLIGHT ROUNDED CURVATURE AT ITS DISTAL APPROXIMATELY 10 MM. NO OTHER DEFORMATION WAS OBSERVED. THE GUIDE WIRE OUTER DIAMETER WAS INSPECTED AND MET THE SPECIFICATION OF THE PRODUCT. NO NOTABLE IRREGULARITY WAS OBSERVED WITH THE RETURNED GUIDE WIRE. THE CAUSE OF THE RESISTANCE FELT WITH THE CATHETER COULD NOT BE IDENTIFIED WITH THE GUIDE WIRE. THE GUIDE WIRE IN QUESTION IS INFERRED TO BE FREE FROM DEFECT. A REVIEW OF THE LOT HISTORY REVEALED NO ANOMALY RELATING TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UN-SPECIFIED PROCEDURE, A TREK BALLOON WAS ADVANCED OVER THE PROWATER GUIDE WIRE; HOWEVER, THE GUIDE WIRE FELT STICKY DURING ADVANCEMENT OF THE BALLOON CATHETER. RESISTANCE WAS NOTED DURING REMOVAL OF THE TREK, ALSO. A NEW GUIDE WIRE WAS USED SUCCESSFULLY WITH THE SAME TREK BALLOON. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28078 ASAHI PROWATER PTCA GUIDE WIRE GUIDE WIRE DQX AV-ASAHI 110805A481

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR DIL CATH: TREK