BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE WHISPER MS GUIDE WIRE

    MDR report key: 2882687 · Received December 20, 2012

    Report

    Report Number
    2024168-2012-08236
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 27, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K101116
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS OF (B)(4) 2012, THE GUIDE WIRE PIECE WAS SUCCESSFULLY REMOVED, THE DISSECTION WAS TREATED, AND BYPASS GRAFTS WERE PERFORMED VIA THE SURGERY. REVIEW OF A RECEIVED CINE OF THE PROCEDURE REVEALED THAT THE TIP OF THE WHISPER MS GUIDE WIRE HAD PROLAPSED, AFTER BALLOON DILATATION, BUT BEFORE GUIDE WIRE SEPARATION. THE CINE REVIEW ALSO CONFIRMED THAT THE DISTAL 9 TO 10 CENTIMETERS OF THE GUIDE WIRE HAD SEPARATED FROM ITS SHAFT. THOUGH THIS ISSUE CAUSED A CLINICALLY SIGNIFICANT DELAY, THERE WERE NO ADVERSE PATIENT SEQUELAE. DILATATION CATHETER: 3.0X12 TREK. GUIDE CATHETER: 7FR RB4. STENT: 3.0X15 VISION (X2). THE 3.0 X 15 RX VISION (LOT NUMBER 2081841) MENTIONED IS BEING FILED UNDER A SEPARATE MANUFACTURER REPORT NUMBER. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE SEPARATION AND PROLAPSED TIP WERE ABLE TO BE CONFIRMED. THE DIFFICULTIES REMOVING THE GUIDE WIRE 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 (SEM) 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 THE PROCEDURE ON (B)(6) 2012, AN 014 WHISPER MS GUIDE WIRE WAS ADVANCED THROUGH A 7-FRENCH NON-ABBOTT GUIDING CATHETER AND PAST A HEAVILY CALCIFIED LESION IN THE DIFFUSELY DISEASED, HEAVILY TORTUOUS MID TO DISTAL RIGHT CORONARY ARTERY. THE LESION WAS PRE-DILATED USING A 3.0X12 TREK BALLOON DILATATION CATHETER. A 3.0X15 VISION STENT DELIVERY SYSTEM (SDS) (LOT NUMBER 2081141) WAS ADVANCED, BUT WAS UNABLE TO CROSS THE LESION AND WAS WITHDRAWN. ANOTHER 3.0X15 VISION SDS (LOT NUMBER 2081841) WAS ALSO ADVANCED BUT WAS UNABLE TO CROSS THE LESION; WHILE WITHDRAWING THE 2ND VISION SDS, RESISTANCE WAS FELT BUT NO FORCE WAS APPLIED, AND THE WHISPER GUIDE WIRE SEPARATED INSIDE OF THE DISTAL RCA. THE REMAINING PROXIMAL PART OF THE WHISPER GUIDE WIRE WAS WITHDRAWN FROM THE ANATOMY. SNARING WAS NOT ATTEMPTED AT THE SITE DUE TO A LACK OF SNARING EQUIPMENT. THE PROCEDURE WAS NOT COMPLETED, MEDICATION (BLOOD THINNER) WAS ADMINISTERED TO THE PATIENT, AND THE PATIENT WAS REFERRED TO ANOTHER HOSPITAL ON (B)(6) 2012 FOR ATTEMPTED SNARING OF THE REMAINING DISTAL PIECE OF THE WHISPER GUIDE WIRE FROM THE ANATOMY. ATTEMPTED SNARING OF THE WHISPER USING A NON-ABBOTT SNARE DEVICE OVER A BALANCE MIDDLEWEIGHT GUIDE WIRE WAS UNSUCCESSFUL; A NON-ABBOTT GUIDING CATHETER USED DURING THE SNARING ATTEMPT REPORTEDLY CAUSED A DISSECTION. ON THE SAME DAY, THE PATIENT SUBSEQUENTLY UNDERWENT CORONARY ARTERY BYPASS (CABG) SURGERY TO TREAT THE DISSECTION, REMOVE THE REMAINING

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE WHISPER MS GUIDE WIRE GUIDE WIRES DQX AV-TEMECULA-CT 2072471

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R| S CONCOMITANT MEDICAL DEVICES