BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER

    MDR report key: 1101691 · Received August 7, 2008

    Report

    Report Number
    2134265-2008-02238
    Event Type
    Injury
    Date Received
    August 7, 2008
    Date of Event
    July 9, 2007
    Report Date
    July 9, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LIT
    PMA / PMN Number
    K960501
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN DISPOSED OF AT THE USER FACILITY AND WILL NOT BE RETURNED FOR EVAL, THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF THERE IS NAY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ABDOMINAL AORTIC ANEURYSM (AAA) STENT GRAFT PLACEMENT PROCEDURE, REMOVAL DIFFICULTIES AND A BALLOON MATERIAL DETACHMENT OCCURRED. THE LESION WAS LOCATED IN THE ABDOMINAL AORTA, HOWEVER, THE PT OF THE STENOSIS OF THE LESION, DEGREE OF CALCIFICATION, AND VESSEL TORTUOSITY ARE UNKNOWN. AN UNSPECIFIED 9FR. INTRODUCER SHEATH WAS PLACED. ANOTHER MANUFACTURER'S BI-ILIAC STENT GRAFT WAS PLACED. THE ULTRA-THIN DIAMOND BALLOON CATHETER WAS ADVANCED TO AN UNSPECIFIED ILIAC ARTERY FOR POST-DILATATION OF THE STENT. THE BALLOON WAS SUCCESSFULLY DEFLATED, HOWEVER, UPON REMOVAL RESISTANCE WAS ENCOUNTERED AND THE BALLOON WAS UNABLE TO BE REMOVED THROUGH THE INTRODUCER SHEATH. A "JERK" WAS APPLIED TO THE BALLOON CATHETER WHICH SHEARED THE BALLOON MATERIAL OFF OF THE BALLOON CATHETER, ALLOWING REMOVAL OF ONLY THE CATHETER WHILE THE BALLOON MATERIAL "HUNG" ON THE END OF THE SHEATH INSIDE THE PT. FEARING THE BALLOON MATERIAL WOULD DISLODGE FROM THE INTRODUCER SHEATH BY ADVANCEMENT OF A SNARE, THE PHYSICIAN DECIDED TO REMOVE THE INTRODUCER SHEATH WITH THE BALLOON MATERIAL. UPON REMOVAL OF THE INTRODUCER SHEATH, THE BALLOON MATERIAL REMAINED INSIDE THE PT. THE PHYSICIAN PERFORMED A CUT-DOWN AND WAS ABLE TO SUCCESSFULLY REMOVE THE BALLOON MATERIAL. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INTERVENTION. APPROXIMATELY TWO WEEKS POST PROCEDURE, THE PT PRESENTED WITH AN INFECTED UNSPECIFIED GROIN. AN UNSPECIFIED SURGICAL PROCEDURE WAS PERFORMED TO TREAT THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention