BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

    MDR report key: 2770835 · Received October 3, 2012

    Report

    Report Number
    2024168-2012-06248
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    September 11, 2012
    Report Date
    September 11, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K072460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. DIL CATH: TREK 1.5 X 20, GUIDE WIRE: PILOT 50. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE COMPLAINT DEVICE WAS RETURNED AND THE REPORTED TIP SEPARATION WAS CONFIRMED. THE REPORTED PHYSICAL RESISTANCE AND PROLAPSED TIP COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON VISUAL AND SCANNING ELECTRON MICROSCOPY (SEM) IMAGING OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. ADDITIONALLY, A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT 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 THE PATIENT WAS BEING TREATED FOR A SEVERE STABLE ANGINA. THE LESION WAS LONG (50MM), VERY TIGHT AND CALCIFIED AT THE CIRCUMFLEX ARTERY, BETWEEN THE 1ST AND 2ND MARGINAL ARTERIES. DURING ADVANCEMENT OF THE BALANCE MIDDLEWEIGHT UNIVERSAL II (BMW UII) GUIDE WIRE, RESISTANCE WAS FELT AND WHEN THE TIP WAS AT THE 2ND MARGINAL BIFURCATION LEVEL IT WAS A LOOP IN THE TIP WAS OBSERVED. A PILOT 50 GUIDE WIRE WAS PLACED IN THE 1ST MARGINAL AND RESISTANCE WAS ALSO FELT DURING ADVANCING THIS GUIDE WIRE. A 1.5 X 20 MM TREK BALLOON WAS USED IN AN ATTEMPT TO REMOVE THE LOOP FROM THE TIP OF THE BMW UII; HOWEVER, THIS WAS UNSUCCESSFUL AND DURING THE ATTEMPT, THE GUIDE WIRE TIP SEPARATED. AFTER REMOVAL OF THE PROXIMAL PART OF THE BMW UII, A PILOT 50 GUIDE WIRE WAS ADVANCED AND PRE-DILATATION OF THE LESION WAS PERFORMED TO EMBED THE GUIDE TIP AGAINST THE ARTERY WALL. THE LESION WAS TREATED WITH 2 NON-ABBOTT STENTS (2.75 X 22 MM AND 2.5 X 26 MM). A RESIDUAL LESION WAS OBSERVED AT THE DISTAL PART, WHERE THE GUIDE TIP WAS LOCATED. POST-DILATATION WAS DONE WITH A 2.5 X 10 MM NON-ABBOTT BALLOON TO SUCCESSFULLY COMPLETE THE PROCEDURE. ALTHOUGH THE PROCEDURE TIME WAS EXTENDED 30 MINUTES (TOTAL 1 HOUR 30 MINUTES), THERE WAS NO ADVERSE PATIENT SEQUELAE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 2072172

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CONCOMITANT MEDICAL DEVICES