BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    MDR report key: 971843 · Received March 23, 2007

    Report

    Report Number
    2182269-2007-00081
    Event Type
    Malfunction
    Date Received
    March 23, 2007
    Date of Event
    September 5, 2006
    Report Date
    March 19, 2007
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO USED PRODUCT WAS RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFO REC'D, THE STORAGE CONDITION OF THE ANGIO-SEAL DEVICES MAY HAVE CONTRIBUTED TO THE PRODUCT DEGRADATION OF THE REPORTED EVENT. THE REMAINING ANGIO-SEALS FROM THE PYXIS STORAGE UNIT WERE RETURNED FOR EVALUATION. LOT NUMBERS 1207718 AND 1223406 WERE RETURNED IN AN OLD USED ANGIO-SEAL 10 PACK CARTON NOT RELATED TO ANY OF THE RETURN LOTS IN QUESTION. INSIDE THE CARTON WERE SIX (6) 8F ANGIO-SEAL DEVICES "LOT NUMBER 1223406" IN THERE UNOPENED STERILE PACKAGING AND ONE (1) 8F ANGIO-SEAL DEVICES "LOT NUMBER 1207718" IN IT'S UNOPENED STERILIE PACKAGING. THE PACKAGING AND CARTON WERE IN GOOD CONDITION. SEVEN (7) 8F ANGIO-SEAL US FINAL ASSEMBLY DEVICES, WERE RETURNED IN THEIR UNOPENED STERILE PACKAGING. THE STERILE PACKAGING AND DEVICES WERE NOT DAMAGED AND IN GOOD CONDITION. THE SIX (6) SHEATHS FROM LOT 1223406 WERE VISUALLY INSPECTED; NO ANOMALY WAS OBSERVED. THE SHEATHS WERE NOT BRITTLE. THE ONE (1) SHEATH FROM LOT 1207718 WAS VISUALLY INSPECTED; A SLIGHT YELLOWING/DISCOLORATION OF THE SHEATH WAS OBSERVED. THE SHEATH CRUMBLED WHEN LIGHT PRESSURE WAS APPLIED USING FINGER TIPS. AN INTERNAL DOCUMENTATION CHANGE WAS MADE TO ADDRESS THE ANGIO-SEAL STS PLUS INSTRUCTIONS FOR USE (IFU) LABELING STATEMENT "KEEP AWAY FROM SUNLIGHT, INCLUDING UV LIGHT." THE STATEMENT OF "INCLUDING UV LIGHT" INCLUDES ULTRAVIOLET LIGHT SUCH AS THAT USED IN PXIS STORAGE UNITS. THUS, THE ANGIO-SEAL BOX LABEL, PACKAGE LABEL AND IFU ALL HAVE THE SYMBOL PRECAUTION AGAINST UV LIGHT EXPOSURE AND THESE INSTRUCTIONS WERE NOT FOLLOWED BY THE HOSP.

    Description of Event or Problem · 1

    IT WAS REPORTED THE ANGIO-SEAL CRUMBLED DURING DEPLOYMENT. THE PHYSICIAN REMOVED AS MUCH OF THE DEVICE AS POSSIBLE FROM THE PUNCTURE TRACT AND BELIEVES ALL WAS REMOVED. ANOTHER DEVICE WAS OPENED AND IT CRUMBLED ALSO. THE ANGIO-SEALS WERE STORED IN A PYXIS STORAGE UNIT. THE TEMPERATURE DOTS WERE UNCHANGED. THE REPRESENTATIVE STATED THE DOTS TURNED BLACK FROM THE HEAT IN THE CAR BEFORE THEY WERE PACKED FOR RETURN. THE 7 REMAINING UNUSED ANGIO-SEALS FROM THE PYXIS STORAGE UNIT WAS REMOVED AND RETURNED TO QUALITY FOR ANALYSIS. LOT 1207718-1-610121, LOT 1223406-6-61021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS 8F ANGIO-SEAL STS PLUS MGB ST. JUDE MEDICAL NA 1199627

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention