BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI PROWATER PTCA GUIDE WIRE

    MDR report key: 6977591 · Received October 25, 2017

    Report

    Report Number
    3003775027-2017-00197
    Event Type
    Injury
    Date Received
    October 25, 2017
    Date of Event
    October 5, 2017
    Report Date
    November 15, 2017
    Manufacturer
    AV-ASAHI
    Product Code
    DQX
    PMA / PMN Number
    K022762
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE ANALYSIS WAS PERFORMED BY ASAHI INTECC. CO. LTD: THE DEVICE WAS RETURNED FOR ANALYSIS. THE SEPARATION AND STRETCHED COILS WERE CONFIRMED. THE ENTRAPMENT OF THE DEVICE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON CIRCUMSTANCES OF THE PROCEDURE. LOT HISTORY REVIEW REVEALED NO ANOMALY RELATING TO THE REPORTED EVENT AND NO OTHER SIMILAR PRODUCT EXPERIENCE REPORT WAS RECEIVED. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE.

    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 EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE DEVICE IS MANUFACTURED BY ASAHI INTECC. CO. LTD. (B)(4). ABBOTT VASCULAR DISTRIBUTES THE DEVICE AND IS RESPONSIBLE FOR MDR REPORTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROCEDURE WAS TO TREAT A TOTALLY OCCLUDED LESION IN THE RIGHT CORONARY ARTERY (RCA). THE PROWATER GUIDE WIRE WAS ADVANCED WITH A BUDDY SPORT GUIDE WIRE. THE LESION WAS PRE-DILATED WITH A BALLOON CATHETER AND THEN TWO STENTS WERE DEPLOYED. THE PROWATER GUIDE WIRE BECAME STUCK WITH THE ANATOMY, SO THE PHYSICIAN PULLED ON THE WIRE AND THE COATING PULLED OFF THE TOP OF THE WIRE AND THE COILS UNRAVELED. WHEN THE GUIDE WIRE WAS REMOVED FROM THE ANATOMY, RADIOPAQUE MARKERS WERE VISIBLE IN THE DEPLOYED STENT. THE GUIDE WIRE LOOKED INTACT HOWEVER IT IS UNKNOWN IF THE COATING OR THE TIP OF THE WIRE WAS SEPARATED. AN ATTEMPT WAS MADE TO SNARE THE SEPARATED PORTION HOWEVER THIS WAS UNSUCCESSFUL. A STENT WAS DEPLOYED EMBEDDING THE SEPARATED WIRE INTO THE VESSEL WALL. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756496 ASAHI PROWATER PTCA GUIDE WIRE GUIDE WIRE DQX AV-ASAHI 170313A091

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention