BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XXL BALLOON DILATATION CATHETER

    MDR report key: 1781639 · Received August 3, 2010

    Report

    Report Number
    2134265-2010-03310
    Event Type
    Injury
    Date Received
    August 3, 2010
    Date of Event
    July 5, 2010
    Report Date
    July 7, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K952063
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: VISUAL AND TACTILE EXAMINATION OF THE RETURNED DEVICE NOTED THAT THE DISTAL TIP AND DISTAL SECTION OF THE BALLOON WERE NOT ATTACHED TO THE DEVICE. A SEVERE SHAFT KINK WAS OBSERVED 120MM DISTAL TO THE STRAIN RELIEF. A SECOND KINK WAS LOCATED AT THE BASE OF THE STRAIN RELIEF. A COMPLETE CIRCUMFERENTIAL TEAR HAD OCCURRED IN THE BALLOON 60MM DISTAL TO THE PROXIMAL BALLOON SLEEVE. THE PROXIMAL SECTION OF THE BALLOON WAS FOLDED WITH TRACES OF DRIED BLOOD VISIBLE INSIDE. BOTH THE PROXIMAL AND DISTAL MARKERBANDS WERE STILL IN THERE ORIGINAL PLACE. THE DISTAL SECTION OF THE SHAFT WAS STRETCHED. NO OTHER ISSUES WERE NOTED WITH THE DEVICE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED USER RELATED AS THE BALLOON WAS INFLATED ABOVE ITS RATED BURST PRESSURE (RBP). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE, A BALLOON RUPTURE AND DISLODGMENT OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE SUBCLAVIAN VEIN. THE 12-4/5.8/75 XXL BALLOON DILATATION CATHETER WAS ADVANCED TO THE LESION AND DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 18 ATMS. A PORTION OF THE BALLOON DETACHED FROM THE DEVICE. THE XXL BALLOON FRAGMENT WAS STENTED AGAINST THE VESSEL WALL OF THE SUBCLAVIAN WITH A 14X40 NON BSC SELF EXPANDING STENT. TREATMENT WAS CONTINUED WITH A NON BSC BALLOON; HOWEVER, THIS DEVICE RUPTURED AS WELL. THE PROCEDURE WAS CONSIDERED COMPLETE WITH THE PLACEMENT OF THE SELF EXPANDING STENT. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE, A BALLOON RUPTURE AND DISLODGMENT OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE SUBCLAVIAN VEIN. THE 12-4/5.8/75 XXL BALLOON DILATATION CATHETER WAS ADVANCED TO THE LESION AND DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 18 ATMS. A PORTION OF THE BALLOON DETACHED FROM THE DEVICE. THE XXL BALLOON FRAGMENT WAS STENTED AGAINST THE VESSEL WALL OF THE SUBCLAVIAN WITH A 14X40 NON BSC SELF EXPANDING STENT. TREATMENT WAS CONTINUED WITH A NON BSC BALLOON; HOWEVER, THIS DEVICE RUPTURED AS WELL. THE PROCEDURE WAS CONSIDERED COMPLETE WITH THE PLACEMENT OF THE SELF EXPANDING STENT. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XXL BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY M001145100 13535080

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention