BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZEPPELIN 1052 6.4F

    MDR report key: 140159 · Received December 22, 1997

    Report

    Report Number
    2951420-1997-00013
    Event Type
    Other
    Date Received
    December 22, 1997
    Date of Event
    August 28, 1997
    Report Date
    December 5, 1997
    Manufacturer
    MEDTRONIC MIS
    Product Code
    DQO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS, OBTAINED FROM THE EVALUATION OF THE RETURNED PRODUCT, SHOWED THAT THE BALLOON OF THE MEDTRONIC MIS CATHETER WAS ECCENTRIC IN SHAPE; THUS, THE BALLOON WAS OUT OF SPECIFICATION AS DETERMINED BY VISUAL EXAMINATION AND PERFORMANCE TESTING OF BALLOON INFLATION. BOTH BALLOON BONDS WERE FOUND TO BE SHEARED CAUSING THE ASYMMETRY. THIS ASYMMETRY COULD HAVE LED TO THE CLINICAL OBSERVATION THAT THE BALLOON WAS NOT FULLY INFLATED. FOLLOWING THE DATE OF MFR OF THIS ZEPPELIN (9/24/1996), A MFG PROCESS CHANGE WAS IMPLEMENTED (10/10/1996) TO PREVENT SHEARING OF THE BALLOON BONDS BY ADDING A ROUGHENING PROCESS TO THE DISTAL TIP OF THE BALLOON BOND. THE OBSERVATION OF INADVERTENT BALLOON DEFLATION COULD NOT BE CONFIRMED; THERE WERE NO OBSERVABLE LEAKS IN THE BALLOON OR ITS BONDS. THE LOT# REPORTED IN BLOCK D6 OF THE INITIAL REPORT HAS BEEN CORRECTED IN BLOCK D6 OF THIS FOLLOWUP REPORT.

    Description of Event or Problem · 1

    ACCORDING TO THE PHYSICIAN, THE BALLOON OF THE MEDTRONIC MIS ZEPPELIN 6.4F MICROCATHETER WAS REPORTED TO NOT BE FULLY INFLATED AT THE OPERATION SITE. THE PHYSICIAN REPORTED THAT DURING AN EMBOLIZATION CASE, A COIL WAS CARRIED AWAY BY THE PT'S BLOODSTREAM BECAUSE THE BALLOON SOON DEFLATED; THIS COIL WAS RETRIEVED. HOWEVER, DURING A SECOND ATTEMPT IN THE SAME WAY, THE SECOND COIL WAS NOT RETRIEVED. THE PT'S CONDITION IS UNKNOWN AT THIS TIME. THE ARTERY AND ANATOMICAL SITE OF OCCURRENCE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZEPPELIN 1052 6.4F ZEPPELIN BALLOON OCCLUSION GUIDING CATHETER DQO MEDTRONIC MIS ZE10704 C0292496-ZE23224

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other