BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1960110 · Received January 13, 2011

    Report

    Report Number
    2024168-2011-00281
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    November 24, 2010
    Report Date
    January 11, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. DEVICE #1 PROGLIDE PART# 12673-03, LOT# 890106H, IS BEING FILED UNDER A SEPARATE MEDWATCH MANUFACTURER REPORT NUMBER. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE DEVICE ATTEMPTED PRE-CLOSE PLACEMENT OF THE PERCLOSE PROGLIDE DEVICE SUTURES IN THE CONTRALATERAL AND IPSILATERAL ARTERIOTOMY SITES PRIOR TO AN INTERVENTIONAL PROCEDURE. REPORTEDLY, DURING SUTURE PLACEMENT IN THE LEFT COMMON FEMORAL ARTERY, WHEN THE NEEDLE PLUNGER WAS REMOVED, THERE WAS NO SUTURE ATTACHED TO THE NEEDLES. THE DEVICE WAS REMOVED OVER A GUIDE WIRE AND A SECOND PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. REPORTEDLY, DURING SUTURE PLACEMENT IN THE RIGHT COMMON FEMORAL ARTERY, WHEN THE NEEDLE PLUNGER WAS REMOVED, THERE WAS NO SUTURE ATTACHED TO THE NEEDLES. THE DEVICE WAS REMOVED OVER A GUIDE WIRE AND A SECOND PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED PATIENT ADVERSE EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 890106H

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention DEVICE #1 PROGLIDE PART# 12673-03, LOT# 890106H.