BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE WHISPER MS GUIDEWIRE

    MDR report key: 831255 · Received March 22, 2007

    Report

    Report Number
    2024168-2007-00102
    Event Type
    Injury
    Date Received
    March 22, 2007
    Date of Event
    February 19, 2007
    Report Date
    February 20, 2007
    Manufacturer
    GUIDANT VASCULAR INTERVENTION
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: QA ANALYSIS REVEALED THAT THE GUIDEWIRE WAS RETURNED WITH BLOOD AND CONTRAST ON THE COILS AND CORE. THE CORE AND COILS HAD DETACHED 6 CM PROXIMAL TO THE TIP BALL. THE DISTAL END OF THE SEPARATION WAS NOT RETURNED. THE FRACTURE FACE ON THE PROXIMAL END OF THE SEPARATION WAS STRETCHED. THERE WAS A BEND IN THE CORE 9.3 CM PROXIMAL TO THE SEPARATION. NO OTHER DAMAGE TO THE GUIDEWIRE WAS NOTED. THIS GUIDEWIRE WAS SENT TO THE LAB FOR FURTHER ANALYSIS. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFO AND THE ANALYSIS OF THE RETURNED DEVICE. RESULTS OF THE SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS INDICATE THAT THE DEVICE CORE WAS SUBJECTED TO EXCESSIVE BENDING BEYOND ITS DESIGN LIMIT CAUSING THE TIP TO DETACH. NORMALLY, FOR THE GUIDEWIRE TO FAIL DUE TO THIS TYPE OF OVERLOAD, SOME PORTION OF THE WIRE TIP WOULD HAVE TO BE TRAPPED EITHER IN THE ANATOMY OR IN ANOTHER DEVICE WHILE EXCESSIVE BENDING FORCE WAS APPLIED. FROM THE INCIDENT DESCRIPTION, THE MECHANISM OF HOW THE TIP BECAME TRAPPED AND HOW FORCE WAS APPLIED WAS NOT DESCRIBED, BUT AS A PERFORATION WAS REPORTED, IT IS LIKELY THAT THE TIP BECAME TRAPPED IN THE PERFORATION SITE ALTHOUGH THE CASE INFO SAID THAT THIS WAS NOT ABLE TO BE SEEN. OVERALL, THE ROOT CAUSE APPEARS TO BE FROM CIRCUMSTANCES DURING THE PROCEDURE. THE LOT HISTORY RECORD WAS REVIEWED AND THERE WERE NO NON-CONFORMITIES ASSOCIATED WITH THIS LOT NUMBER. A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO SIMILAR COMPLAINTS REPORTED WITH THIS PART AND LOT NUMBER COMBINATION. THIS IS A VERY LOW-LEVEL FAILURE MODE THAT IS MONITORED. MFG ASSURES THE QUALITY OF THE WIRE TIPS THROUGH VISUAL AND DIMENSIONAL INSPECTIONS AND 100% NON-DESTRUCIVE PULL TEST OF THE TIP. ALSO, SAMPLES ARE DESTRUCTIVELY TESTED TO FAILURE AND EACH LOT MUST PASS THE TEST REQUIREMENTS. QUALITY INSPECTION VERIFIES THAT ALL REQUIREMENTS ARE MET. THIS MDR IS CONSIDERED CLOSED BY THE PRODUCT PERFORMANCE GROUP.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY - MEDICAL/SURGICAL INTERVENTION. REPORTING RATIONALE: GUIDEWIRE SEPARATION REQUIRING MEDICAL AND SURGICAL INTERVENTION. DEVICE ISSUE: GUIDEWIRE SEPARATION. IT WAS REPORTED THAT DURING WITHDRAWAL OF THE WHISPER GUIDEWIRE FROM THE CIRCUMFLEX ARTERY, THE DISTAL TIP OF THE GUIDEWIRE BROKE OFF. THE REMAINING GUIDEWIRE WAS WITHDRAWN LEAVING THE DISTAL TIP OF THE GUIDEWIRE INSIDE A SIDE BRANCH. THE REMAINING GUIDEWIRE BECAME DIFFICULT TO SEE. THIS OCCURRED AT THE END OF THE PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE. APPROX FOUR HOURS LATER, THE PT WAS DIAGNOSED WITH TAMPONADE AND A DRAIN WAS INSERTED ON THE WARD. THE PT SUBSEQUENTLY WAS TAKEN TO SURGERY. THE GUIDEWIRE TIP, WHICH HAD PIERCED THE MYOCARDIUM, WAS SURGICALLY REMOVED. REPORTEDLY THE PT IS STABLE AND RECOVERING. NO ADD'L EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE WHISPER MS GUIDEWIRE 74DQX DQX GUIDANT VASCULAR INTERVENTION NA 6112958

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| R