BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPER SHEATH INTRODUCER SHEATH

    MDR report key: 1832570 · Received September 13, 2010

    Report

    Report Number
    2134265-2010-04173
    Event Type
    Injury
    Date Received
    September 13, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 23, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DRE
    PMA / PMN Number
    K052557
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: ANALYSIS OF THE RETURNED DEVICE REVEALED THE SHEATH TUBE WAS BROKEN 7MM FROM THE HUB. A KINK WAS NOTED 87MM FROM THE TIP. THE BROKEN PORTION OF THE RETURNED PRODUCT WAS VIEWED UNDER MAGNIFICATION. A CUT MADE BY A SHARP INSTRUMENT WAS FOUND ON A PART OF THE BROKEN PORTION AND THE REST WAS PULLED AND DETACHED. DIMENSIONAL INSPECTION NOTED THE DEVICE MET 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 DIAGNOSTIC PROCEDURE, THE HUB DETACHED FROM THE INTRODUCER SHEATH.A DIAGNOSTIC LEFT HEART CATH WAS PERFORMED WITHOUT INCIDENT. WHILE REMOVING THE 6F X 11CM SUPER SHEATH OVER THE CLOSURE DEVICE WIRE, THE HUB OF THE SHEATH DETACHED INCLUDING APPROXIMATELY 5MM OF THE CATHETER. THE REST OF THE CATHETER PORTION REMAINED IN THE PATIENT. A SURGEON WAS CALLED TO THE CATH LAB AND A CUT DOWN WAS PERFORMED TO THE ARTERY TO LOCATE THE REMAINING PORTION OF THE SUPER SHEATH. A CLAMP WAS PLACED ON THE DEVICE AND IT WAS ABLE TO BE REMOVED FROM THE PATIENT. THE PATIENT WAS ADMITTED FOR OBSERVATION AND DISCHARGED THE NEXT DAY. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DIAGNOSTIC PROCEDURE, THE HUB DETACHED FROM THE INTRODUCER SHEATH. A DIAGNOSTIC LEFT HEART CATH WAS PERFORMED WITHOUT INCIDENT. WHILE REMOVING THE 6F X 11CM SUPER SHEATH OVER THE CLOSURE DEVICE WIRE, THE HUB OF THE SHEATH DETACHED INCLUDING APPROXIMATELY 5MM OF THE CATHETER. THE REST OF THE CATHETER PORTION REMAINED IN THE PATIENT. A SURGEON WAS CALLED TO THE CATH LAB AND A CUT DOWN WAS PERFORMED TO THE ARTERY TO LOCATE THE REMAINING PORTION OF THE SUPER SHEATH. A CLAMP WAS PLACED ON THE DEVICE AND IT WAS ABLE TO BE REMOVED FROM THE PATIENT. THE PATIENT WAS ADMITTED FOR OBSERVATION AND DISCHARGED THE NEXT DAY. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER SHEATH INTRODUCER SHEATH DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE BOSTON SCIENTIFIC - MAPLE GROVE H7491603506B1 10E19B9

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R