BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI PROWATER PTCA GUIDE WIRE

    MDR report key: 4064314 · Received September 5, 2014

    Report

    Report Number
    3003775027-2014-00044
    Event Type
    Injury
    Date Received
    September 5, 2014
    Date of Event
    August 9, 2014
    Report Date
    August 13, 2014
    Manufacturer
    AV-ASAHI
    Product Code
    DQX
    PMA / PMN Number
    K022762
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 INTECC. CO. LTD. MEDICAL DIVISION; HOWEVER, ABBOTT VASCULAR DISTRIBUTES THE DEVICE AND IS RESPONSIBLE FOR MDR REPORTING. THE ANALYSIS WAS PERFORMED BY ASAHI INTECC. CO. LTD., THE DEVICE WAS NOT RETURNED FOR INVESTIGATION AND A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. BASED ON THE PROVIDED INFORMATION, IT COULD NOT BE DETERMINED WHETHER THE GUIDE WIRE MAY HAVE CONTRIBUTED TO THE RELATED EVENTS, HOWEVER, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY. IT SHOULD BE NOTED AS LISTED IN THE INSTRUCTIONS FOR USE (IFU), THIS GUIDE WIRE MUST BE USED ONLY BY A PHYSICIAN WHO IS FULLY TRAINED IN PTCA/PTA TREATMENT, AND DAMAGE TO A VESSEL AS POSSIBLE COMPLICATIONS AND ADVERSE EVENTS OF GUIDEWIRE USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY USING A NON-ABBOTT STENT AND GUIDE CATHETER AND PROWATER GUIDE WIRE, THE STENT DELIVERY SYSTEM (SDS) COULD NOT CROSS THE LESION. THE SDS WAS REMOVED FOR ADDITIONAL PRE-DILATATION, HOWEVER, IT WAS NOTED THAT THE NON-ABBOTT GUIDE CATHETER CAUSED A DISSECTION OF THE LEFT MAIN (LM) WHEN IT DISLODGED FROM PLACE IN THE AORTA. WHILE ATTEMPTING TO REPOSITION THE GUIDE CATHETER THE PROWATER GUIDE WIRE WAS PULLED/TUGGED AND THE LEFT MAIN OCCLUDED. THE VESSEL WAS RE-WIRED AND AN ADDITIONAL STENT WAS PLACED AS TREATMENT OF THE LEFT MAIN WITHOUT REPORTED ADVERSE PATIENT SEQUELA. A NON-ABBOTT STENT WAS SUCCESSFULLY DEPLOYED IN THE TARGET LESION WITHOUT 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
    544791 ASAHI PROWATER PTCA GUIDE WIRE GUIDE WIRE DQX AV-ASAHI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R