BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCIMED TRANSEND EX STEERABLE GUIDE WIRE AND ACCESSORIES

    MDR report key: 1901842 · Received November 17, 2010

    Report

    Report Number
    2939204-2010-01090
    Event Type
    Injury
    Date Received
    November 17, 2010
    Date of Event
    October 10, 2010
    Report Date
    November 2, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K934122
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THAT APPROXIMATELY 2CM OF THE TIP WAS MISSING, EXPOSING THE FRACTURED COREWIRE. SCANNING ELECTRON MICROSCOPY OF THE FRACTURE NOTED THAT THE FRACTURE SURFACE EXHIBITED FATIGUE STRIATIONS ALONG WITH PRIMARY ELONGATED DIMPLE RUPTURES AND MICROCRACKS WITH SOME EVIDENCE OF TORSION. NO MATERIAL ANOMALIES WERE NOTED. IT WAS CONCLUDED THAT THE FRACTURE OCCURRED AS A RESULT OF FATIGUE PRIMARILY IN A CYCLIC BENDING OVERLOAD ACTION WITH SOME EVIDENCE OF TORTION. BASED ON THE INVESTIGATION AND THE INFORMATION PROVIDED, IT WAS DETERMINED THAT OPERATIONAL CONTEXT WAS THE MOST LIKELY CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE TIP OF THE GUIDEWIRE DETACHED IN THE TORTUOUS INTERNAL CAROTID ARTERY (ICA). THE PHYSICIAN SUCCESSFULLY REMOVED THE GUIDEWIRE TIP WITH A SNARE DEVICE FROM THE PATIENT'S BODY. THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE TIP OF THE GUIDEWIRE DETACHED IN THE TORTUOUS INTERNAL CAROTID ARTERY (ICA). THE PHYSICIAN SUCCESSFULLY REMOVED THE GUIDEWIRE TIP WITH A SNARE DEVICE FROM THE PATIENT'S BODY. THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE TIP OF THE GUIDEWIRE DETACHED. THE PHYSICIAN SUCCESSFULLY REMOVED THE GUIDEWIRE TIP FROM THE PATIENT'S BODY. THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCIMED TRANSEND EX STEERABLE GUIDE WIRE AND ACCESSORIES WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA M001468050 0013562703

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention 6FR ENVOY GUIDE CATHETER (CORDIS)