BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 3253349 · Received July 29, 2013

    Report

    Report Number
    2024168-2013-04748
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    July 14, 2013
    Report Date
    July 18, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    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. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. REVIEWS OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RESISTANCE WAS MET AS THE RX TREK BALLOON DILATATION CATHETER WAS VERY QUICKLY ADVANCED THROUGH THE 6F LAUNCHER JR4 GUIDE CATHETER. AS THE PROXIMAL SEGMENT OF THE TREK WAS BEING ADVANCED, THE DISTAL END DID NOT EXIT THE GUIDE CATHETER BECAUSE THE RX TREK SHAFT HAD SEPARATED. THE GUIDE CATHETER WAS REMOVED ALONG WITH THE ENTIRE RX TREK. THE PROWATER GUIDEWIRE REMAINED IN PLACE TO MAINTAIN VESSEL ACCESS. A NON-ABBOTT BALLOON WAS USED WITH ANOTHER JR4, OVER THE SAME PROWATER, IN THE MID RIGHT CORONARY ARTERY TO COMPLETE THE PROCEDURE WITHOUT FURTHER INCIDENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354040 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR PROWATER GUIDE WIRE, 6F JR4 LAUNCHER GUIDE CATH