BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE

    MDR report key: 2911477 · Received January 11, 2013

    Report

    Report Number
    2024168-2013-00247
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 18, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. CONCOMITANT MEDICAL PRODUCT: DIL CATH: SAPPHIRE1.0-10. THE DEVICE HAS BEEN RETURNED FOR EVALUATION. IT IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED AND THE REPORTED DIFFICULTY POSITIONING AND REMOVING THE GUIDE WIRE/RESISTANCE WAS CONFIRMED VIA RETURNED DEVICE ANALYSIS. HOWEVER, THERE WAS NO FOREIGN MATERIAL NOTED ON THE COILS OTHER THAN BLOOD AND CONTRAST. BASED ON VISUAL INSPECTION, DIMENSIONAL AND FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. ADDITIONALLY, A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NONCONFORMANCES WITH THE REPORTED LOT AND A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE DISTAL TO PROXIMAL RIGHT CORONARY ARTERY (RCA) AND CIRCUMFLEX ARTERY, THE BALANCE MIDDLEWEIGHT (BMW) HC GUIDE WIRE WAS USED IN THE RCA; HOWEVER, WHEN ATTEMPTED TO BE USED IN THE CIRCUMFLEX WITH A NON-ABBOTT BALLOON DILATATION CATHETER (BDC) RESISTANCE WAS MET. THE DEVICES WERE REMOVED AND A NEW BMW HC WAS USED WITHOUT ISSUE. HOWEVER, SOME FOREIGN MATERIAL WAS PRESENT ON THE USED GUIDE WIRE COILS. IT WAS NOTED THAT THE SAME BDC WAS ADVANCED WITHOUT ISSUE OVER THE GUIDE WIRE. THERE WAS NO 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
    17557 ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 2070571

    Patients

    Seq Age Sex Outcome Treatment
    1