BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 1912586 · Received December 2, 2010

    Report

    Report Number
    2953144-2010-03055
    Event Type
    Injury
    Date Received
    December 2, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 9, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.DEVICE#1:PROSTAR (PART#12322-02, LOT# UNKNOWN) IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE DEVICE SUCCESSFULLY PERFORMED PRE-CLOSURE PLACEMENT OF THE PROSTAR XL SUTURES IN BILATERAL ARTERIOTOMY SITES PRIOR TO AN INTERVENTIONAL PROCEDURE. REPORTEDLY, "AT THE END OF THE LONG 4.5 HOUR PROCEDURE, THE HOLE COULD NOT BE CLOSED WITH THE SUTURES." IT WAS BELIEVED THAT THE ENTRY HOLE WAS WIDE, AS MULTIPLE SHEATH EXCHANGES HAD OPENED THE ORIGINAL HOLE. A VASCULAR SURGEON DID A CUT DOWN AND SUTURED THE HOLE TO ACHIEVE HAEMOSTASIS." REPORTEDLY, DURING ARTERIOTOMY CLOSURE OF THE CONTRALATERAL VESSEL, AFTER DEPLOYING THE SUTURE, AS THE KNOT WAS ADVANCED ON THE GREEN SUTURE, RESISTANCE WAS FELT, THE RAIL PART OF THE SUTURE WAS PULLED, AND THE SUTURE SNAPPED. THE PHYSICIAN DID NOT USE THE ADVANCER BUT HE WAS USING HIS HANDS WHEN THIS HAPPENED. THE SURGEON HAD TO DO A CUT DOWN AND SUTURED THE HOLE TO ACHIEVE HAEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTAR XL SUTURE-MEDIATED CLOSURE SUTURE MEDIATED CLOSURE MGB AV-REDWOOD CITY

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention DEVICE#1:PROSTAR XL(PART 12322-02,LOT UNKNOWN)