BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE WHISPER MS GUIDE WIRE

    MDR report key: 3130744 · Received May 24, 2013

    Report

    Report Number
    2024168-2013-03288
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    April 24, 2013
    Report Date
    May 2, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K101116
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. DILATATION CATHETER: TERUMO (B)(4) 1.25/10 - BOSTON SCIENTIFIC MAVERICK MONORAIL 20/30 STENT: MEDTRONIC RESOLUTE INTEGRITY 2.25/30 IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SUBSEQUENT TO THE MEDWATCH REPORT, ADDITIONAL REPORTED INFORMATION INDICATES THAT THE TARGET VESSEL WAS MILDLY CALCIFIED AND MODERATELY TORTUOUS. DURING INSPECTION OF THE GUIDE WIRE PRIOR TO USE, NO ANOMALIES WERE NOTED AND NO SHAPING OF THE GUIDE WIRE TIP WAS PERFORMED. THE GUIDE WIRE WAS ADVANCED BUT RESISTANCE WAS FELT; THEREFORE, PRE-DILATATION WAS PERFORMED. AGAIN THE GUIDE WIRE WAS ADVANCED AND UNUSUAL RESISTANCE WAS FELT. THE GUIDE WIRE SEPARATED PROXIMAL TO THE RADIOPAQUE SEGMENT, APPROXIMATELY 8 CM FROM THE TIP WITHOUT CROSSING THE LESION. THE PATIENT INITIALLY REMAINED CLINICALLY STABLE; HOWEVER, AFTER PERCUTANEOUS ATTEMPTS TO REMOVE THE SEPARATED SEGMENT WITH A CATHETER, THE PATIENT EXPERIENCED PERICARDIAL PAIN DESPITE THE VESSEL REMAINING ACCESSIBLE AND OPEN. THEN, THE PATIENT WAS TRANSFERRED TO CARDIO-SURGERY FOR URGENT INTERVENTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE FIRST MARGINAL BRANCH OF THE CIRCUMFLEX ARTERY, A .014 WHISPER GUIDE WIRE AND 6F GUIDE CATHETER WERE ADVANCED VIA RIGHT RADIAL ACCESS. A NON-ABBOTT DILATATION CATHETER WAS ADVANCED AND DILATATION WAS PERFORMED SUCCESSFULLY. A NON-ABBOTT STENT DELIVERY SYSTEM WAS ADVANCED WITH SOME RESISTANCE DUE TO TORTUOSITY AND CALCIFICATION OF THE VESSEL. JUST PRIOR TO REACHING THE TARGET LESION, THE GUIDE WIRE WAS OBSERVED TO BE SEPARATED (8-9CM). THE GUIDE WIRE SEPARATION OCCURRED INSIDE THE MONORAIL OF THE NON-ABBOTT STENT SYSTEM. THERE WAS NO APPARENT CAUSE FOR THE SEPARATION AND THE GUIDE WIRE WAS NOT SUBJECTED TO UNUSUAL STRESS. SEVERAL UNSUCCESSFUL ATTEMPTS WERE MADE TO REMOVE THE GUIDE WIRE USING A PERCUTANEOUS APPROACH. THE PATIENT WAS URGENTLY TRANSFERRED TO ANOTHER HOSPITAL WHERE SURGICAL INTERVENTION WAS PERFORMED TO REMOVE THE GUIDE WIRE AND PERFORM CORONARY ARTERY BYPASS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231973 HI-TORQUE WHISPER MS GUIDE WIRE GUIDE WIRES DQX AV-TEMECULA-CT 3020371

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S