BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V-14¿ CONTROLWIRE®

    MDR report key: 2882319 · Received December 20, 2012

    Report

    Report Number
    2134265-2012-08054
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    November 30, 2012
    Report Date
    December 3, 2012
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    DQX
    PMA / PMN Number
    K112745
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR., EVAL SUMMARY ATTACHED, METHOD CODES, RESULT CODES, CONCLUSION CODES: UPDATED. DEVICE EVALUATED BY MANUFACTURER: VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED THE POLYMER SLEEVE SECTION PEELED AT ITS MOST DISTAL SIDE ABOUT 1CM DAMAGED ALSO DEVICE IS KINKED AND BENT. NO EVIDENCE OF WIRE FRACTURE. DEVICE APPEARS TO HAVE BEEN PULLED/PUSHED AGAINST RESISTANCE. OUTER DIAMETER MEASUREMENTS ARE WITHIN THE SPECIFICATIONS. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERIPHERAL ANGIOPLASTY PROCEDURE, A GUIDE WIRE TIP DETACHED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 60% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED DORSAL PEDIS ARTERY. A 300CM V-14 CONTROLWIRE WAS SUCCESSFULLY ADVANCED TO THE TARGET LESION. HOWEVER DURING USE, THE TIP OF THE V-14 CONTROLWIRE BROKE OFF IN THE DORSAL PEDIS ARTERY AND DID NOT MIGRATE. THE DETACHED TIP WAS RETRIEVED USING A SNARE. THE PROCEDURE WAS COMPLETED WITH A NON BSC DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS LISTED AS OK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERIPHERAL ANGIOPLASTY PROCEDURE, A GUIDE WIRE TIP DETACHED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 60% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED DORSAL PEDIS ARTERY. A 300CM V-14 CONTROLWIRE WAS SUCCESSFULLY ADVANCED TO THE TARGET LESION. HOWEVER DURING USE, THE TIP OF THE V-14 CONTROLWIRE BROKE OFF IN THE DORSAL PEDIS ARTERY AND DID NOT MIGRATE. THE DETACHED TIP WAS RETRIEVED USING A SNARE. THE PROCEDURE WAS COMPLETED WITH A NON BSC DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS LISTED AS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V-14¿ CONTROLWIRE® WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (COYOL) H74939216730010 15496583

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CATHETER, TRAILBLAZER SUPPORT CATHETER