BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER

    MDR report key: 1830124 · Received September 10, 2010

    Report

    Report Number
    2134265-2010-03888
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    August 13, 2010
    Report Date
    August 13, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K960501
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. 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

    SAME CASE AS MFR#: 2134265-2010-04019. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A BALLOON DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT EXTERNAL ILIAC ARTERY. ANOTHER MANUFACTURER'S 6F INTRODUCER SHEATH WAS USED TO FACILITATE THE ADVANCEMENT OF A 7X55MM REDUCED PROFILE WALLSTENT STENT DELIVERY SYSTEM (SDS). THE WALLSTENT WAS ADVANCED TO THE LESION AND AN ATTEMPT TO DEPLOY THE STENT WAS MADE. DURING STENT DEPLOYMENT, THE PHYSICIAN HAD DIFFICULTY SEEING THE STENT UNDER FLUORO. UPON DEPLOYMENT OF THE STENT, ONLY THE DISTAL PORTION OF THE STENT WAS LOCATED OUTSIDE THE INTRODUCER SHEATH. THE PROXIMAL SECTION OF THE STENT BECAME ONLY PARTIALLY DEPLOYED BECAUSE IT WAS STILL LOCATED INSIDE THE INTRODUCER SHEATH. THE PHYSICIAN WAS UNAWARE OF THIS AT THE TIME DUE TO THE VISIBILITY ISSUES. THINKING THE STENT WAS FULLY DEPLOYED, THE PHYSICIAN WITHDREW THE SDS, WHILE LEAVING THE INTRODUCER SHEATH IN POSITION FOR POST-DILATION. A 6X6MM UT DIAMOND BALLOON CATHETER WAS INSERTED AND ADVANCED THROUGH THE PARTIALLY DEPLOYED STENT. DILATION WAS PERFORMED JUST DISTAL TO THE STENT, THE LOCATION WHERE THE PHYSICIAN THOUGHT THE STENT WOULD BE. DURING REMOVAL OF THE BALLOON CATHETER, THE BALLOON CATHETER PULLED THE ENTIRE WALLSTENT INTO THE INTRODUCER SHEATH. THE FORCE USED TO REMOVE THE BALLOON CATHETER CAUSED THE ENTIRE BALLOON TO DETACH. THE INTRODUCER SHEATH WAS REMOVED FROM THE PATIENT CONTAINING THE ENTIRE BALLOON AND THE STENT IN THE HUB OF THE SHEATH. THERE WERE NO FRAGMENTS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY UNK463

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention STENT: 7X55MM REDUCED PROFILE WALLSTENT| INTRODUCER SHEATH: 6F RABBE