BEUDAMED
    FDA Adverse Event Death Summary report: N

    HI-TORQUE WHISPER MS GUIDE WIRE

    MDR report key: 1131723 · Received August 21, 2008

    Report

    Report Number
    2024168-2008-00698
    Event Type
    Death
    Date Received
    August 21, 2008
    Date of Event
    July 21, 2008
    Report Date
    July 25, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    DQX
    PMA / PMN Number
    K013092
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: PRODUCT PERFORMANCE ENGINEERING WAS UNABLE TO COMPLETE THEIR ANALYSIS AT THE TIME OF THIS REPORT. RESULTS AND CONCLUSIONS WILL BE FORWARDED UPON COMPLETION. EVALUATION SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE GUIDE WIRE WAS RETURNED WITHOUT ANY BLOOD OR CONTRAST VISIBLE. THE CORE WAS SEPARATED 26.6 CM DISTAL TO THE PROXIMAL END OF THE COILS. THE SEPARATED PORTION WAS NOT RETURNED. THE MATERIAL WAS STRETCHED AND JAGGED AT THE SEPARATION. THERE WERE TWO KINKS IN THE CORE, 3 MM AND 6 MM PROXIMAL TO THE SEPARATION. THERE WAS NO OTHER DAMAGE NOTED TO THE GUIDE WIRE. THE CATHETER USED DURING THE PROCEDURE WAS NOT RETURNED. FOUR ADDITIONAL UNOPENED GUIDE WIRES WERE RETURNED AS PRODUCT ASSOCIATED COMPLAINTS (PAC'S). ALL FOUR GUIDE WIRES HAD PART NUMBER REF 1005357H AND LOT NUMBER 8032593. THERE WAS NO DAMAGE NOTED TO THE FOUR PAC'S. A SNAP GAUGE WAS USED TO MEASURE THE OUTER DIAMETERS OF THE GUIDE WIRE. THE OUTER DIAMETER MET MANUFACTURING CRITERIA. A SNAP GAUGE WAS USED TO MEASURE THE OUTER DIAMETERS OF THE FOUR GUIDE WIRE RETURNED AS PAC'S. THE OUTER DIAMETERS MET MANUFACTURING CRITERIA. THE DISTAL END OF THE GUIDE WIRE WAS DIPPED INTO CONGO RED DYE TO CONFIRM THAT THERE WAS HYDROPHILIC COATING PRESENT ON THE GUIDE WIRE. THE RETURNED GUIDEWIRE WAS BACKLOADED THROUGH A NEW CATHETER. THERE WAS RESISTANCE NOTED ONLY AS THE KINKS IN THE CORE ADVANCED THROUGH THE CATHETER. THE DISTAL END OF ALL FOUR GUIDE WIRES RETURNED AS PAC'S WAS DIPPED INTO CONGO RED DYE TO CONFIRM THAT THERE WAS HYDROPHILIC COATING PRESENT ON THE GUIDE WIRE. THE FOUR GUIDE WIRES RETURNED AS PAC'S WERE BACKLOADED THROUGH A NEW CATHETER. THERE WAS NO RESISTANCE NOTED. THE SEPARATED GUIDE WIRE WAS SENT TO THE LAB FOR FURTHER ANALYSIS. PRODUCT PERFORMANCE ENGINEERING WAS UNABLE TO COMPLETE THEIR ANALYSIS AT THE TIME OF THIS REPORT RESULTS AND CONCLUSIONS WILL BE FORWARD UPON COMPLETION.

    Description of Event or Problem · 1

    REPORTED STATUS: DEATH. REPORTING RATIONALE: SEPARATED GUIDE WIRE REMAINS IN PATIENT/DEATH. DEVICE ISSUE: SEPARATED GUIDE WIRE. IT WAS REPORTED THAT THE INITIAL PROCEDURE WAS PERFORMED ON THE EVENT DATE, AND LASTED APPROXIMATELY THREE HOURS. THE PROCEDURE WAS TO TREAT A LESION IN THE MID RCA. THE WHISPER GUIDE WIRE WAS THE FIRST GUIDE WIRE USED IN THE CASE AND IT CROSSED THE LESION WITH NO RESISTANCE NOTED. THE BALLOON CATHETER WAS ADVANCED OVER THE GUIDE WIRE, HOWEVER, RESISTANCE WAS NOTED. AFTER DILATATION WAS PERFORMED THE BALLOON CATHETER WAS REMOVED AND THEN THE GUIDE WIRE WAS REMOVED. AFTER REMOVAL IT WAS NOTICED THAT THE GUIDE WIRE TIP HAD SEPARATED AND WAS MISSING. ANOTHER COMPANY'S GUIDE WIRE WAS SELECTED AND ADVANCED, HOWEVER, WITH GREAT DIFFICULTY CROSSING THE LESION. TWO OTHER COMPANY'S STENTS WERE THEN PLACED SUCCESSFULLY. THE SEPARATED GUIDE WIRE TIP COULD BE SEEN ON FLUOROSCOPY AND HAD FLOATED DOWN STEAM. THE PHYSICIAN INFORMED THE PT THAT IT WAS A VERY SMALL PIECE AND HE DID NOT FEEL THAT THIS WOULD CAUSE ANY PROBLEMS. THE PT WAS DISCHARGED. THE PT RETURNED TO THE ER FOUR DAYS LATER, COMPLAINING OF CHEST PAIN AND PASSED AWAY THAT NIGHT. NO ADDITIONAL EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE WHISPER MS GUIDE WIRE DQX ABBOTT VASCULAR-CARDIAC THERAPIES NA 8030691

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death DIL CATH: MAVERICK| GUIDE WIRE: CHOICE EXTRA SUPPORT| STENT: LIBERTE(2)