BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1932373 · Received December 17, 2010

    Report

    Report Number
    2953144-2010-03281
    Event Type
    Injury
    Date Received
    December 17, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 22, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (CONCOMITANT MEDICAL PRODUCTS): PERCLOSE PROGLIDE (2) (PART# 12673-03, LOT# 940046H). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. DEVICES #2 AND #3: PERCLOSE PROGLIDE DEVICES (PART# 12673-03, LOT# 940046H), INDICATED ARE BEING FILED UNDER SEPARATE MANUFACTURER MFR NUMBERS. (B)(6).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE YIELDED THE FOLLOWING OBSERVATIONS: THE PLUNGER WAS STILL IN THE PRE-DEPLOYED POSITION AND THERE WAS NO SLACK PRESENT ON THE LINK. THE MARKER TUBE APPEARED NORMAL AND THE MARKER PORT IS NOT OCCLUDED. MARKING PATENCY WAS PERFORMED AND THE DEVICE WAS PATENT. THERE WAS NO ABNORMAL OBSERVATION WITH THE CONDITION OF THE RETURNED DEVICE THAT COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. BASED ON THE INVESTIGATION FINDINGS THE DEVICE CONFORMED TO SPECIFICATION AND A ROOT CAUSE FOR THE REPORTED COMPLAINT RELATED TO THE DEVICE COULD NOT BE DETERMINED. NO MANUFACTURING OR QUALITY ISSUE WAS DETECTED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN, TRAINED IN THE USE OF THE PROGLIDE DEVICE, ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY, IN AN OBESE PATIENT, AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, THE DEVICE COULD NOT GET MARKING. TWO ADDITIONAL PROGLIDE DEVICES WERE ATTEMPTED WITH THE SAME RESULTS. HEMOSTASIS WAS ACHIEVED USING A NON-ABBOTT DEVICE. THERE WAS NO ADVERSE PATIENT EFFECT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE POCKET WAS CLOSED, DFT TESTING WAS PERFORMED. DURING DFT TESTING, THE PATIENT HAD TO BE EXTERNALLY RESCUED BY EXTERNAL DEFIBRILLATION TO BREAK THE VF EPISODE. AN ERROR MESSAGE SHOWED, POSSIBLE OUTPUT CIRCUIT DAMAGE. THE DEVICE WAS EXPLANTED AND REPLACED.

    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-REDWOOD CITY 940046H

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention CONCOMITANT MEDICAL PRODUCTS