BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOURNEY¿

    MDR report key: 2943153 · Received February 5, 2013

    Report

    Report Number
    2134265-2013-00395
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 7, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQX
    PMA / PMN Number
    K081021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - THE CORE WIRE AND HIGH TORQUE SLEEVE (HTS) WERE FRACTURED. THE DISTAL TIP, INCLUDING THE COIL WIRE/CORE WIRE/RIBBON (CCR JOINT) WAS NOT RETURNED FOR ANALYSIS. THE REMAINING HTS MEASURED 6.5" LONG FROM THE FRACTURE TO THE ADHESIVE RAMP. MAGNIFIED INSPECTION OF THE FRACTURED END OF THE HTS PRESENTED EVIDENCE OF A DUCTILE OVERLOAD FRACTURE. THE CORE WIRE FRACTURE SURFACE WAS BENT, INDICATING THAT THE FRACTURE MAY BE ATTRIBUTABLE TO DUCTILE BEND OVERLOAD. THE REPORTED TIP SEPARATION WAS CONFIRMED. MAGNIFIED INSPECTION OF THE FRACTURED ENDS OF THE CORE WIRE AND HTS CONFIRMED THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, A GUIDE WIRE DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE ANTERIOR TIBIAL ARTERY BELOW THE KNEE. DURING MULTIPLE ADVANCEMENT AND PULLBACK MANEUVERS, 3-4CM OF THE DEVICE WAS "CUT" AND REMAINED IN THE PATIENT'S VESSEL. NO ATTEMPT WAS MADE TO REMOVE THE DETACHED SECTION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, A GUIDE WIRE DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE ANTERIOR TIBIAL ARTERY BELOW THE KNEE. DURING MULTIPLE ADVANCEMENT AND PULLBACK MANEUVERS, 3-4CM OF THE DEVICE WAS "CUT" AND REMAINED IN THE PATIENT'S VESSEL. NO ATTEMPT WAS MADE TO REMOVE THE DETACHED SECTION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48300 JOURNEY¿ WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MAPLE GROVE M001391280 15354941

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other