BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIPHERAL CUTTING BALLOON

    MDR report key: 2023745 · Received March 18, 2011

    Report

    Report Number
    2134265-2011-00856
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 22, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K041993
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: (B)(6). DEVICE EVALUATED BY MANUFACTURER: 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, DEFLATION DIFFICULTIES AND CATHETER REMOVAL DIFFICULTIES WERE ENCOUNTERED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED EXTERNAL ILIAC ARTERY. THE PHYSICIAN ADVANCED THE 8.00MM X /2.0CM/135CM OTW PERIPHERAL CUTTING BALLOON (PCB) ACROSS THE LESION, INFLATED THE BALLOON ONCE TO 6 ATMS, AND DIFFICULTIES DEFLATING THE BALLOON WERE ENCOUNTERED. THE PHYSICIAN ATTEMPTED TO REMOVE THE PCB THOUGH THE INTRODUCER SHEATH BY PULLING THE PCB ¿SEVERAL TIMES¿, HOWEVER, THESE ATTEMPTS WERE UNSUCCESSFUL. THE PHYSICIAN INFLATED AND DEFLATED THE PCB A COUPLE OF TIMES AND THE PCB FINALLY DEFLATED. THE PHYSICIAN REMOVED THE PCB CATHETER THROUGH THE SHEATH AND OUTSIDE OF THE PATIENT. THE BLADES WERE INTACT AND NO DAMAGE TO THE BLADES WAS NOTED. THE AREA OF THE PCB SHAFT PROXIMAL TO THE BALLOON APPEARED TO BE ELONGATED, BUT WAS INTACT. NEXT, THE PHYSICIAN ADVANCED AN 8MM X 2MM NON-BSC BALLOON CATHETER, INFLATED THE BALLOON, AND THE BALLOON RUPTURED. IT IS NOT KNOWN HOW THE PHYSICIAN COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERIPHERAL CUTTING BALLOON CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA LIT BOSTON SCIENTIFIC - GALWAY M001PCB80201350

    Patients

    Seq Age Sex Outcome Treatment
    1