BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

    MDR report key: 2895387 · Received January 3, 2013

    Report

    Report Number
    2024168-2013-00037
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 8, 2012
    Report Date
    December 10, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K072460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    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 EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDED INTRAVASCULAR ULTRASOUND. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED RESISTANCE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT DUE TO THE CONDITION OF THE RETURNED DEVICE. WHILE THE SITE WAS NOT AWARE OF THE SEPARATION, DURING THE DEVICE EVALUATION, IT WAS NOTED THAT THE SHAPING RIBBON HAD SEPARATED FROM THE GUIDE WIRE CORE. BASED ON A VISUAL AND DIMENSIONAL INSPECTION AND SCANNING ELECTRON MICROSCOPY (SEM) IMAGING OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE TO TREAT A NON-CALCIFIED, DE NOVO LESION IN THE NON-TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY, WHILE BOTH ADVANCING AND WITHDRAWING AN UNSPECIFIED INTRAVASCULAR ULTRASOUND (IVUS) CATHETER OVER A BALANCE MIDDLEWEIGHT (BMW) UNIVERSAL II GUIDE WIRE THAT HAD BEEN PLACED IN THE ANATOMY, RESISTANCE WAS FELT BETWEEN THE TWO DEVICES. BOTH THE IVUS AND BMW WERE REMOVED FROM THE ANATOMY AS A SINGLE UNIT. THE PROCEDURE WAS COMPLETED USING A NEW BMW UNIVERSAL II GUIDE WIRE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL FILED REPORT, AN ANALYSIS OF THE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE BY THE ABBOTT VASCULAR RETURNED GOODS LAB REVEALED THAT THE SHAPING RIBBON HAD SEPARATED FROM THE GUIDE WIRE CORE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE SITE WAS NOT AWARE OF A CORE SEPARATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3496 HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 2100871

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4)| DIAGNOSTIC CATHETER: INTRAVASCULAR ULTRASOUND