BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATI

    MDR report key: 2494453 · Received March 16, 2012

    Report

    Report Number
    2024168-2012-01723
    Event Type
    Malfunction
    Date Received
    March 16, 2012
    Date of Event
    February 22, 2012
    Report Date
    February 22, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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). EVALUATION SUMMARY: ANALYSIS OF THE RETURNED DEVICE CONFIRMED THE REPORTED FAILURE TO REMOVE THE BALANCE MIDDLEWEIGHT GUIDE WIRE FROM THE STENT DELIVERY SYSTEM (SDS), AS THE GUIDE WIRE WAS RETURNED FROZEN IN THE SDS. BASED ON VISUAL, FUNCTIONAL AND DIMENSIONAL ANALYSIS 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. RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FROM THIS LOT 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 PROCEDURE WAS TO TREAT A 99% STENOSED LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY WITH MILD TORTUOSITY AND MILD CALCIFICATION. AFTER PRE-DILATATION THE 3.0 X 2.5 MM XIENCE SBA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED. A BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE WAS ADVANCED TO THE SIDE BRANCH, BUT COULD NOT CROSS THE DISTAL END OF THE LESION. AN ATTEMPT WAS THEN MADE TO REMOVE THE BMW GUIDE WIRE, SO THE TIP COULD BE RE-SHAPED; HOWEVER, THE GUIDE WIRE BECAME STUCK WITH THE XIENCE SBA SDS. MULTIPLE ATTEMPTS WERE MADE TO REMOVE THE GUIDE WIRE, BUT WERE UNSUCCESSFUL; THEREFORE, THE GUIDE WIRE AND THE SDS WERE REMOVED AS A UNIT, WITHOUT ISSUE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATI GUIDE WIRE DQX AV-TEMECULA-CT 0032671

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE CATH: MEDTRONIC