BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE WHISPER MS GUIDE WIRE

    MDR report key: 2770767 · Received October 3, 2012

    Report

    Report Number
    2024168-2012-06240
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    September 11, 2012
    Report Date
    September 13, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K101116
    Adverse Event
    Yes
    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. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE SEPARATION WAS ABLE TO BE CONFIRMED. BASED ON A VISUAL INSPECTION AND SCANNING ELECTRON MICROSCOPY 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 A PERCUTANEOUS CORONARY INTERVENTION TO TREAT A DE NOVO, CONCENTRIC LESION IN THE PROXIMAL TO MID LEFT CIRCUMFLEX WITH MODERATE TORTUOSITY, HEAVY CALCIFICATION AND 90% STENOSIS, A WHISPER MS GUIDE WIRE WAS ADVANCED TO THE LEFT ANTERIOR DESCENDING ARTERY AS A PROTECT WIRE AND A NON-ABBOTT GUIDE WIRE WAS ADVANCED TO THE PROXIMAL LEFT CIRCUMFLEX AND 1ST MARGINAL. A NON-ABBOTT ROTABLATION DEVICE WAS ADVANCED AND ROTABLATION WAS PERFORMED; HOWEVER, THE WHISPER MS GUIDE WIRE SEPARATED IN THE LESION AND THE SEPARATED PORTION WAS RETRIEVED WITH A SNARE DEVICE. REPORTEDLY, THE PHYSICIAN STATED THAT THE WHISPER MS GUIDE WIRE SEPARATION MAY HAVE OCCURRED DUE TO THE NON-ABBOTT ROTABLATION DEVICE, BUT DID NOT KNOW FOR CERTAIN THAT IT WAS THE NON-ABBOTT ROTABLATION DEVICE THAT CAUSED THE SEPARATION. A STENT WAS IMPLANTED AT THE TARGET LESION AND THE PROCEDURE WAS COMPLETED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE WHISPER MS GUIDE WIRE GUIDE WIRES DQX AV-TEMECULA-CT 2061371

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GUIDE WIRE: ROTAWIREOTHER: ROTABLATER