BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V-14? CONTROLWIRE®

    MDR report key: 4143372 · Received October 6, 2014

    Report

    Report Number
    2134265-2014-05892
    Event Type
    Injury
    Date Received
    October 6, 2014
    Report Date
    September 9, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (HEREDIA)
    Product Code
    DQX
    PMA / PMN Number
    K112745
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RETURNED WITH ITS ORIGINAL POUCH. THE UNIT RETURNED HAS THE DISTAL END KINKED AND PEELED, AS PART OF OVERALL VISUAL REVISION. A VISUAL INSPECTION WAS PERFORMED. THE DISTAL TIP KINKED AND PEELED EXPOSING THE COREWIRE. NO EVIDENCE OF FRACTURE ON THE COREWIRE WAS FOUND. ALL THE OUTER DIAMETER (ODS) TAKEN AND OVERALL LENGTH WERE ACCORDING TO 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 THE GUIDE WIRE COATING PEELED AND REMOVAL DIFFICULTY OCCURRED. THE TARGET LESION WAS LOCATED IN THE DISTAL ANTERIOR TIBIAL ARTERY. A 300CM V-14¿ CONTROL WIRE® GUIDE WIRE WAS SELECTED. A RUBICON CATHETER WAS INSERTED OVER THE V-14 WIRE TO THE LESION; HOWEVER, UPON REMOVAL OF THE V-14 WIRE, RESISTANCE WAS NOTICED. THE PHYSICIAN GAVE A SLIGHT TUG AND THE WIRE CAME OUT OF THE RUBICON CATHETER WITH NO PROBLEM. THE PHYSICIAN STEPPED BACK ON FLUOROSCOPY TO SEND DOWN THE WIRE AND NOTICED SOMETHING SITTING IN THE DORSALIS PEDIS ARTERY. UPON FURTHER EXAMINATION OF THE IMAGES AND THE V-14 WIRE, IT WAS DETERMINED THAT SOME OF THE COATING FROM THE V-14 WIRE HAD SHEARED OFF AND LODGED IN THE DORSALIS PEDIS ARTERY. THE FLOW IN AND AROUND THE LEFT BEHIND COATING WAS GOOD SO THE PHYSICIAN CHOOSE TO LEAVE IT ALONE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GUIDE WIRE COATING PEELED AND REMOVAL DIFFICULTY OCCURRED. THE TARGET LESION WAS LOCATED IN THE DISTAL ANTERIOR TIBIAL ARTERY. A 300CM V-14¿ CONTROLWIRE® GUIDE WIRE WAS SELECTED. A RUBICON CATHETER WAS INSERTED OVER THE V-14 WIRE TO THE LESION; HOWEVER, UPON REMOVAL OF THE V-14 WIRE, RESISTANCE WAS NOTICED. THE PHYSICIAN GAVE A SLIGHT TUG AND THE WIRE CAME OUT OF THE RUBICON CATHETER WITH NO PROBLEM. THE PHYSICIAN STEPPED BACK ON FLUOROSCOPY TO SEND DOWN THE WIRE AND NOTICED SOMETHING SITTING IN THE DORSALIS PEDIS ARTERY. UPON FURTHER EXAMINATION OF THE IMAGES AND THE V-14 WIRE, IT WAS DETERMINED THAT SOME OF THE COATING FROM THE V-14 WIRE HAD SHEARED OFF AND LODGED IN THE DORSALIS PEDIS ARTERY. THE FLOW IN AND AROUND THE LEFT BEHIND COATING WAS GOOD SO THE PHYSICIAN CHOOSE TO LEAVE IT ALONE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622770 V-14? CONTROLWIRE® WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) H74939216730010 17026753

    Patients

    Seq Age Sex Outcome Treatment
    1 Other BALLOON CATHETER: RUBICON .014