BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V-18 CONTROL WIRE

    MDR report key: 2032549 · Received March 29, 2011

    Report

    Report Number
    2134265-2011-00993
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 28, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K033742
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: VISUAL EXAMINATION OF THE RETURNED PRODUCT REVEALED A FRACTURE IN THE DISTAL POLY TIP. THE FRACTURE WAS LOCATED 298CM FROM THE PROXIMAL END. SEM LAB ANALYSIS CONCLUDED THE FRACTURE OCCURRED IN A TORSIONAL OVERLOAD DIRECTION IN A BENDING MOMENT. 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, THE GUIDE WIRE TIP DETACHED. THE >90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND SEVERELY TORTUOUS POSTERIOR TIBIAL ARTERY (PTA). AFTER MORE THAN ONE ATTEMPT TO CROSS THE LESION WITH THE V-18 GUIDE WIRE, THE TIP DETACHED. THE APPROXIMATE LENGTH OF THE WIRE TIP WAS 2.5CM AND IT REMAINED IN THE PATIENT'S DISTAL PTA AT PROCEDURE END. TREATMENT WAS NOT COMPLETED AT THIS TIME. TWO DAYS POST PROCEDURE, THE PATIENT UNDERWENT SURGERY TO TREAT THE TARGET LESION AND REMOVE THE GUIDE WIRE TIP. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, THE GUIDE WIRE TIP DETACHED. THE >90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND SEVERELY TORTUOUS POSTERIOR TIBIAL ARTERY (PTA). AFTER MORE THAN ONE ATTEMPT TO CROSS THE LESION WITH THE V-18 GUIDE WIRE, THE TIP DETACHED. THE APPROXIMATE LENGTH OF THE WIRE TIP WAS 2.5CM AND IT REMAINED IN THE PATIENT'S DISTAL PTA AT PROCEDURE END. TREATMENT WAS NOT COMPLETED AT THIS TIME. TWO DAYS POST PROCEDURE, THE PATIENT UNDERWENT SURGERY TO TREAT THE TARGET LESION AND REMOVE THE GUIDE WIRE TIP. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V-18 CONTROL WIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA M001468600 13586001

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention