BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V-14? CONTROLWIRE®

    MDR report key: 3932922 · Received July 14, 2014

    Report

    Report Number
    2134265-2014-04071
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: UNIT RETURNED WITH ITS ORIGINAL POUCH BATCH. THE UNIT RETURNED HAS THE DISTAL TIP DAMAGE, AS PART OF OVERALL VISUAL REVISION. UNIT RETURNED MATCHES WITH UPN PROVIDED BY THE CUSTOMER. THE VISUAL INSPECTION WAS PERFORMED AND THE DEVICE PRESENTS: THE DISTAL TIP KINKED AND PEELED. ALL THE OUTER DIAMETER (OD) TAKEN 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT COATING ISSUE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE SUPERIOR FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN THE POSTERIOR TIBIAL ARTERY. A 300CM V-14¿ CONTROLWIRE® GUIDE WIRE WAS SELECTED AND ADVANCED TO THE TARGET LESION. WHILE ADVANCING, THE PHYSICIAN NOTICED THAT THE WIRE LOOPED ITSELF SO, HE TRIED TO UNLOOP IT BY GOING BACK AND FORTH HOWEVER, IT LOOPED FURTHER. A .018 UNSPECIFIED SUPPORT CATHETER WAS THEN ADVANCED THROUGH THE WIRE TO PULL IT AND UNDO THE LOOP BUT IT GOT STUCK IN. THE PHYSICIAN KEPT ON PULLING THE WIRE USING A LITTLE BIT MORE FORCE AND WHEN IT CAME BACK, IT WAS NOTICED THAT A LITTLE PIECE WAS LEFT IN THE ARTERY. FOLLOWING WITHDRAWAL, THE PHYSICIAN FOUND OUT THAT THE HYDROPHYLIC COATING WAS SHEARED OFF. THE FRAGMENT WAS THEN RETRIEVED OUT FROM THE PATIENT USING A SNARING DEVICE. THE PHYSICIAN THEN SELECTED A NON-BSC GUIDE WIRE AND DID ATHERECTOMY WITH AN ATHERECTOMY DEVICE AND COMPLETED THE PROCEDURE USING AN UNSPECIFIED SIZE COYOTE BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT COATING ISSUE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE SUPERIOR FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN THE POSTERIOR TIBIAL ARTERY. A 300CM V-14¿ CONTROLWIRE® GUIDE WIRE WAS SELECTED AND ADVANCED TO THE TARGET LESION. WHILE ADVANCING, THE PHYSICIAN NOTICED THAT THE WIRE LOOPED ITSELF SO, HE TRIED TO UNLOOP IT BY GOING BACK AND FORTH HOWEVER, IT LOOPED FURTHER. A .018 UNSPECIFIED SUPPORT CATHETER WAS THEN ADVANCED THROUGH THE WIRE TO PULL IT AND UNDO THE LOOP BUT IT GOT STUCK IN. THE PHYSICIAN KEPT ON PULLING THE WIRE USING A LITTLE BIT MORE FORCE AND WHEN IT CAME BACK, IT WAS NOTICED THAT A LITTLE PIECE WAS LEFT IN THE ARTERY. FOLLOWING WITHDRAWAL, THE PHYSICIAN FOUND OUT THAT THE HYDROPHYLIC COATING WAS SHEARED OFF. THE FRAGMENT WAS THEN RETRIEVED OUT FROM THE PATIENT USING A SNARING DEVICE. THE PHYSICIAN THEN SELECTED A NON-BSC GUIDE WIRE AND DID ATHERECTOMY WITH AN ATHERECTOMY DEVICE AND COMPLETED THE PROCEDURE USING AN UNSPECIFIED SIZE COYOTE BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411250 V-14? CONTROLWIRE® WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) H74939216730020 16761824

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention