BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER

    MDR report key: 1982298 · Received February 9, 2011

    Report

    Report Number
    2134265-2011-00393
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 13, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K960501
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. 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 AN ANGIOPLASTY TREATMENT PROCEDURE DEFLATION AND REMOVAL DIFFICULTIES OCCURRED. THE 70% STENOSED LESION WAS LOCATED IN THE NON-CALCIFIED FISTULA IN THE ARM. THE PHYSICIAN ADVANCED THE ULTRA-THIN DIAMOND BALLOON CATHETER AND INFLATED THE BALLOON TWICE TO 14 ATMS. IT WAS NOTED THAT THE BALLOON TOOK 'A FEW SECONDS' TO DEFLATE AND THAT IT WAS 'NOT COMING DOWN EFFECTIVELY'. THE PHYSICIAN ATTEMPTED TO REMOVE THE BALLOON THROUGH THE 7FR INTRODUCER SHEATH, HOWEVER, THE BALLOON DID NOT REWRAP PROPERLY AND DIFFICULTIES WERE ENCOUNTERED REMOVING THE ULTRA-THIN BALLOON FROM THE PATIENT. THE PHYSICIAN REMOVED THE BALLOON, GUIDE WIRE AND INTRODUCER SHEATH AS A UNIT TO COMPLETE THE PROCEDURE. NO 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 M001165050

    Patients

    Seq Age Sex Outcome Treatment
    1 INSTRODUCER SHEATH: TERUMO