BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPER SHEATH INTRODUCER SHEATH

    MDR report key: 2972340 · Received February 21, 2013

    Report

    Report Number
    2134265-2013-00803
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 23, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DRE
    PMA / PMN Number
    K052557
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR., EVAL SUMMARY ATTACHED, METHOD CODES, RESULT CODES, CONCLUSION CODES: UPDATED. DEVICE EVALUATED BY MANUFACTURER: EXAMINATION OF THE RETURNED DEVICE REVEALED THE SHEATH TUBE WAS BROKEN AT THE LOCATION OF 38 MM FROM THE SHEATH TIP. THE BROKEN PART OF THE RETURNED PRODUCT WAS OBSERVED AND MAGNIFIED. IT WAS CONFIRMED THAT A CUT ON THE SHEATH TUBE MADE BY SHARP INSTRUMENT WAS FOUND ON THE BROKEN PART. IT APPEARED THE REST OF THE BROKEN PART WAS PULLED AND DETACHED WHEN BEING PULLED OUT IN THE PROCEDURE. 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). AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DECLOT PROCEDURE OF A COMPLETELY BLOCKED LEFT THIGH GRAFT, SHEATH BREAK OCCURRED. THE GRAFT WAS SUCCESSFULLY DECLOTTED WITH ANGIOPLASTY, TISSUE PLASMINOGEN ACTIVATOR AND HEPARIN. AT CONCLUSION OF PROCEDURE, DURING ATTEMPT TO REMOVE THE 6 FR X 7 SUPER SHEATH THERE WAS NO DIFFICULTY OR RESISTANCE WHEN PULLING THE SHEATH BACK, HOWEVER THE DEVICE BROKE IN HALF LEAVING THE DISTAL PORTION OF THE SHEATH INSIDE THE PATIENT. THE PHYSICIAN ATTEMPTED TO REMOVE THE SHEATH FRAGMENT VIA ACCESS WITH UPSIZE 8F SHEATH AND AN INFLATED BALLOON CATHETER; TRIED PULLING THE SHEATH BACK WITH THE BALLOON BUT THE SHEATH FRAGMENT WOULD NOT MOVE. THE PATIENT WAS TAKEN TO SURGERY, A SMALL INCISION WAS MADE AND THE SHEATH FRAGMENT WAS SUCCESSFULLY REMOVED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATENT'S STATUS IS LISTED AS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DECLOT PROCEDURE OF A COMPLETELY BLOCKED LEFT THIGH GRAFT, SHEATH BREAK OCCURRED. THE GRAFT WAS SUCCESSFULLY DECLOTTED WITH ANGIOPLASTY, TISSUE PLASMINOGEN ACTIVATOR AND HEPARIN. AT CONCLUSION OF PROCEDURE, DURING ATTEMPT TO REMOVE THE 6 FR X 7 SUPER SHEATH THERE WAS NO DIFFICULTY OR RESISTANCE WHEN PULLING THE SHEATH BACK, HOWEVER THE DEVICE BROKE IN HALF LEAVING THE DISTAL PORTION OF THE SHEATH INSIDE THE PATIENT. THE PHYSICIAN ATTEMPTED TO REMOVE THE SHEATH FRAGMENT VIA ACCESS WITH UPSIZE 8F SHEATH AND AN INFLATED BALLOON CATHETER; TRIED PULLING THE SHEATH BACK WITH THE BALLOON BUT THE SHEATH FRAGMENT WOULD NOT MOVE. THE PATIENT WAS TAKEN TO SURGERY, A SMALL INCISION WAS MADE AND THE SHEATH FRAGMENT WAS SUCCESSFULLY REMOVED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATENT'S STATUS IS LISTED AS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76186 SUPER SHEATH INTRODUCER SHEATH DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE BOSTON SCIENTIFIC - MAPLE GROVE M00115957B1 12G17B8

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention