BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASAHI PROWATER PTCA GUIDE WIRE

    MDR report key: 3645700 · Received February 25, 2014

    Report

    Report Number
    3003775027-2014-00016
    Event Type
    Malfunction
    Date Received
    February 25, 2014
    Date of Event
    December 10, 2013
    Report Date
    January 31, 2014
    Manufacturer
    AV-ASAHI
    Product Code
    DQX
    PMA / PMN Number
    K022762
    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. (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL 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).EVALUATION SUMMARY:INVESTIGATION OF THE DIMENSIONS OF THE RETURNED PROWATER REVEALED THAT THE GUIDEWIRE MEETS THE PRODUCTS SPECIFICATIONS WITH NO DISCREPANCY. THOUGH THE LOT HISTORY COULD NOT BE REVIEWED AS NO LOT INFORMATION WAS AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. ALL SHIPPED PRODUCTS ARE INSPECTED IN THE PRODUCTION PROCESS FOR MEETING PRODUCT SPECIFICATIONS AND THE RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT USING A FEMORAL ARTERY ACCESS APPROACH DURING A VASCULAR INTERVENTION PROCEDURE TO CLEAR A CHRONIC TOTAL OCCLUSION IN THE POSTERIOR TIBIAL VESSEL A NON-ABBOTT 0.9 LASER CATHETER WAS USED TO TREAT THE APPROXIMATELY 220 MM LENGTH AND AFTER 2 PASSES AND AN INCREASE IN SETTINGS TO TREAT THE CALCIFIED VESSEL THE PHYSICIAN SWITCHED THE GUIDE WIRE FOR A PROWATER GUIDE WIRE. UPON INTRODUCTION OF THE PROWATER WIRE RESISTANCE WAS MET AND DIFFICULTY ADVANCING AS THE WIRE WAS GETTING STUCK IN THE CATHETER; REGARDLESS, THE PHYSICIAN WAS ABLE TO POSITION THE GUIDE WIRE IN THE DESIRED LOCATION AND IT APPEARED OK. A THIRD PASS WITH THE LASER CATHETER WAS STARTED BUT STOPPED WITHIN A FEW SECONDS AS THE PHYSICIAN NOTED THAT THE CATHETER FELT HOT TO THE TOUCH. NO INJURY WAS REPORTED TO THE PATIENT AND IT WAS VERIFIED UNDER FLUOROSCOPY THAT NO PERFORATION OR VESSEL INJURY HAD OCCURRED. DURING REMOVAL OF THE LASER, THE GUIDE WIRE WAS STUCK AND IT COULD NOT BE REMOVED WITHOUT LOSING ACCESS. THE DEVICES WERE REMOVED TOGETHER AS A SYSTEM AND OUTSIDE THE ANATOMY IT WAS NOTED THAT THE NON-ABBOTT LASER CATHETER HAD SEVERAL BROKEN FIBERS AND A SLIGHT PERFORATION IN THE OUTER JACKET WHICH MAY HAVE RESULTED DURING POSITIONING OR REMOVAL. THE PATIENT WAS TREATED USING ANGIOPLASTY WITHOUT FURTHER DIFFICULTY. 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
    116503 ASAHI PROWATER PTCA GUIDE WIRE GUIDE WIRE DQX AV-ASAHI

    Patients

    Seq Age Sex Outcome Treatment
    1 OTHER:SPECTRANETICS 0.9 TURBO ELITE LASER CATHETER