BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    MDR report key: 2130238 · Received June 10, 2011

    Report

    Report Number
    2182269-2011-00104
    Event Type
    Injury
    Date Received
    June 10, 2011
    Report Date
    June 10, 2011
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT LOT NUMBER WAS UNK; HOWEVER THE CUSTOMER REPORTED THAT THE PRODUCT WAS FROM ONE OF TWO LOTS, 3251333 OR 3218548. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THE SUBJECT LOTS (3251333 AND 3218548) BOTH MET MFG REQUIREMENTS PRIOR TO SHIPMENT. THE MFG AND USE BY/BEFORE DATE ARE AS FOLLOWS: LOT 3251333: MFG DATE: 11/01/2010; USE BY/BEFORE DATE: 10/31/2011. LOT 3218548: MFG DATE: 10/01/2010: USE BY/BEFORE DATE: 09/30/2011. BASED ON THE INFO PROVIDED TO ST. JUDE MED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) STATES THAT BLEEDING OR A HEMATOMA AT THE PUNCTURE SITE IS A POSSIBLE RISK OR SITUATION THAT MAY BE ASSOCIATED WITH THE USE OF THE DEVICE OR VASCULAR ACCESS PROCEDURES. IF THIS SHOULD OCCUR, THE IFU INSTRUCTS THE USER TO APPLY DIGITAL OR MANUAL PRESSURE TO THE PUNCTURE SITE AND IF NECESSARY, MONITOR PEDAL PULSES. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) STATES THAT A SINGLE WALL PUNCTURE TECHNIQUE SHOULD BE USED. THE POSTERIOR WALL OF THE ARTERY SHOULD NOT BE PUNCTURED.

    Description of Event or Problem · 1

    IT WAS REPORTED FOLLOWING A PERCUTANEOUS INTERVENTION PROCEDURE (PCI), AN ANGIO-SEAL STS PLUS WAS SELECTED FOR USE. A PRE-DEPLOYMENT ANGIOGRAM REVEALED A COMMON FEMORAL ARTERY (CFA) WITH A 6.0 MM LUMEN DIAMETER WITH NO CALCIFICATION IDENTIFIED. A 6F TERUMO SHEATH WAS ALSO USED DURING THE PROCEDURE. THE ANGIO-SEAL WAS DEPLOYED WITHOUT ANY PROBLEM. APPROX EIGHTEEN HOURS AFTER DEPLOYMENT, THE PT AMBULATED AND BLEEDING FROM THE PUNCTURE SITE WAS OBSERVED AND MANUAL COMPRESSION WAS APPLIED. THE PT UNDERWENT EMERGENCY SURGERY (DATE UNK) AND THE ANGIO-SEAL WAS REMOVED. THE SURGICAL NOTES INDICATED THE ANCHOR HAD PROTRUDED OUT OF THE ARTERY. THE COMPLAINT PRODUCT USED MAY HAVE BEEN FROM LOT NUMBER 3251333 OR 3218548. ADD'L INFO WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS ANGIO-SEAL DEVICE MGB ST. JUDE MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R