BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI PROWATER PTCA GUIDE WIRE

    MDR report key: 6768987 · Received August 4, 2017

    Report

    Report Number
    3003775027-2017-00139
    Event Type
    Injury
    Date Received
    August 4, 2017
    Date of Event
    July 12, 2017
    Report Date
    August 28, 2017
    Manufacturer
    AV-ASAHI
    Product Code
    DQX
    PMA / PMN Number
    K022762
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL FILE NUMBER - (B)(4). THE ANALYSIS WAS PERFORMED BY ASAHI INTECC. CO. LTD. ALTHOUGH DEVICE INVESTIGATION OF THE SUBJECT PROWATER COULD NOT BE CONDUCTED, SINCE ALL THE SHIPPED PRODUCTS WERE INSPECTED IN THE PRODUCTION PROCESS FOR MEETING THE PRODUCT SPECIFICATIONS AND RELEASE CRITERIA, THERE WAS NO INDICATION OF PRODUCT DEFICIENCY. BASED ON THE PROVIDED INFORMATION, IT WAS INFERRED THAT THE REPORTED VESSEL PERFORATION WAS RELATED TO THE ANATOMICAL CONDITION AND WIRE MANIPULATION TECHNIQUE. THE DEVICE IS MANUFACTURED BY ASAHI INTECC. CO. LTD. (B)(4), REGISTRATION NUMBER: (B)(4). ABBOTT VASCULAR DISTRIBUTES THE DEVICE AND IS RESPONSIBLE FOR MDR REPORTING.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. AN ANGIOGRAM CONFIRMED OCCLUSION OF THE GRAFTMASTER STENT IN THE MID PDA, WHICH WAS DUE TO THE SMALL CALIBER OF VESSEL AND DUE TO POOR RUN-OFF DISTAL TO THE STENT. DURING BALLOON ANGIOPLASTY TO RESTORE FLOW, THROMBUS WAS FOUND IN THE STENT AND AT THE DISTAL STENT EDGE. AS THE DISTAL VESSEL SIZE AND RUN-OFF WERE TOO SMALL TO PERFORM ADDITIONAL PERCUTANEOUS INTERVENTIONS, THE PATIENT WAS DISCHARGED HOME (B)(6) 2017 ON DUAL ANTI-PLATELET THERAPY MEDICATION WITH NO FURTHER COMPLICATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED. CONCOMITANT MEDICAL PRODUCTS: GUIDE WIRE: HI-TORQUE WHISPER MS, GUIDE CATHETER: BOSTON SCIENTIFIC 6FR FR3.5, STENT: 3.5X38MM BOSTON SCIENTIFIC PROMUS PREMIER. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE HI-TORQUE WHISPER MS REFERENCED, AND THE RX GRAFTMASTER REFERENCED ARE BEING FILED UNDER SEPARATE MANUFACTURING REPORT NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT PRESENTED WITH A NON-ST-ELEVATED MYOCARDIAL INFARCTION (MI) AND BACK PAIN. A NON-ABBOTT 6FR FR3.5 GUIDING CATHETER WAS PLACED VIA RADIAL ACCESS, FOLLOWED BY ADVANCEMENT OF A HI-TORQUE WHISPER MS GUIDE WIRE (GW) TO THE RIGHT CORONARY ARTERY (RCA) THEN ADVANCEMENT OF AN ASAHI PROWATER 180CM GUIDE WIRE TO THE POSTERIOR DESCENDING ARTERY (PDA) VIA RADIAL ARTERY ACCESS. PRE-DILATATIONS WERE THEN PERFORMED WITH MULTIPLE NON-ABBOTT BALLOONS, FOLLOWED BY DEPLOYMENT OF A 3.5X38MM NON-ABBOTT DRUG-ELUTING STENT, COVERING A LONG, 90% STENOSED LESION IN THE PROXIMAL RCA AND A 60% STENOSED LESION IN THE MID RCA. A FREE PERFORATION (APPROXIMATELY 2.5MM IN SIZE) WAS THEN NOTED IN THE PDA. REPORTEDLY, THE CAUSE OF THE PERFORATION IS UNEXPLAINED AND EITHER OF THESE GUIDE WIRES MAY HAVE CAUSED OR CONTRIBUTED TO THE PERFORATION; IT WAS NOTED ON ANGIOGRAPHY THAT THE WHISPER GUIDE WIRE HAD REMAINED IN THE LOOPED (PROLAPSED) POSITION DURING THE ENTIRE PROCEDURE, WHICH MAY HAVE CONTRIBUTED TO PERFORATION. HEPARIN DRUG REVERSAL AND BALLOON TAMPONADE DID NOT RESOLVE THE PERFORATION. THUS, A 2.8X16MM RX GRAFTMASTER COVERED STENT WAS DEPLOYED AT 13 ATMOSPHERES, SUCCESSFULLY RESOLVING THE PERFORATION. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS DISCHARGED HOME ON (B)(6) 2017 WITH NO FURTHER COMPLICATIONS. ON (B)(6) 2017, THE PATIENT RETURNED TO THE EMERGENCY ROOM WITH GRADUAL ONSET CHEST PAIN (10/10 PAIN) WITH NO RELIEF AFTER TAKING THREE SL NITROGLYCERINE TABLETS. AN ELECTROCARDIOGRAM INDICATED AN ACUTE INFERIOR ST-ELEVATED MI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546685 ASAHI PROWATER PTCA GUIDE WIRE GUIDE WIRE DQX AV-ASAHI 161025A061

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention