BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE WHISPER ES GUIDE WIRE

    MDR report key: 3132925 · Received May 29, 2013

    Report

    Report Number
    2024168-2013-03327
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 3, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K101116
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE SEPARATION WAS ABLE TO BE CONFIRMED. THE FAILURE TO ADVANCE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON A VISUAL AND DIMENSIONAL 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. IT SHOULD BE NOTED THE HI-TORQUE WINN GUIDE WIRE INSTRUCTIONS FOR USE STATES: DO NOT PUSH, AUGER, WITHDRAW, OR TORQUE A GUIDE WIRE THAT MEETS RESISTANCE. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(4). THE GUIDE WIRE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, ADDITIONAL INFORMATION INDICATES THAT THERE WAS NO RESISTANCE FELT DURING WITHDRAWAL OF THE GUIDE WIRE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE HEAVILY CALCIFIED AND HEAVILY TORTUOUS RIGHT CORONARY ARTERY (RCA) WITH POSSIBLE THROMBUS, SEVERAL UNSUCCESSFUL ATTEMPTS WERE MADE TO ADVANCE AND TORQUE THE .014 WHISPER LS GUIDE WIRE TO THE DISTAL SEGMENT OF THE VESSEL. A DISSECTION WAS NOTED. DURING THE ATTEMPT TO WITHDRAW THE GUIDE WIRE, THE TIP OF THE GUIDE WIRE SEPARATED. THE GUIDE WIRE TIP REMAINS IN THE ANATOMY. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE AND REMAINED HOSPITALIZED FOR MONITORING. ANGIOPLASTY IS NOT POSSIBLE DUE TO THE SEVERE CALCIFICATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235513 HI-TORQUE WHISPER ES GUIDE WIRE GUIDE WIRES DQX AV-TEMECULA-CT 3012771

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| O