BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3190436 · Received June 26, 2013

    Report

    Report Number
    2024168-2013-03982
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 11, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED EVENT WAS CONFIRMED. BASED ON THE VISUAL INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. BASED ON THE MANUFACTURING INSPECTION CRITERIA AND ANALYSIS OF THE RETURNED DEVICE, THE PROBABLE CAUSE WAS DETERMINED TO BE INCORRECT DEPLOYMENT TECHNIQUE. INSPECTION OF THE RETURNED DEVICE INDICATED THAT THE RAIL SUTURE ALONG WITH ITS DETACHABLE POSTERIOR NEEDLE TIP WAS DRAWN INTO THE GUIDE TUBE. THIS IS CONSISTENT WITH RETRACTING THE PLUNGER PRIOR TO DEPRESSING IT TO DEPLOY THE NEEDLES. THIS IS INCORRECT DEPLOYMENT SEQUENCE PER INSTRUCTIONS FOR USE WHICH STATES: WHILE MAINTAINING DEVICE POSITION, DEPLOY NEEDLES BY PUSHING ON THE PLUNGER ASSEMBLY UNTIL THE COLLAR OF THE PLUNGER MAKES CONTACT WITH THE PROXIMAL END OF THE BODY. VISUALLY CONFIRM THAT THE COLLAR OF THE PLUNGER IS IN CONTACT WITH THE BODY OF THE DEVICE. DISENGAGE THE NEEDLES BY PULLING THE PLUNGER ASSEMBLY BACK AND COMPLETELY REMOVE THE PLUNGER AND NEEDLES FROM THE BODY OF THE DEVICE. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE OTHER PROGLIDE DEVICES REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUTURE PLACEMENT USING TWO PROGLIDE DEVICES WAS SUCCESSFUL IN THE COMMON FEMORAL ARTERY USING THE PRECLOSE TECHNIQUE PRIOR TO AN ABDOMINAL AORTIC ANEURYSM (AAA) PROCEDURE. THE ARTERIOTOMY WAS 7F. THE ARTERIOTOMY WAS UPSIZED TO 24 F AND THE AAA PROCEDURE WAS COMPLETED. REPORTEDLY, AFTER THE AAA PROCEDURE, DURING THE ARTERIOTOMY CLOSURE, THE KNOTS SEEMED LOOSE AFTER KNOT ADVANCEMENT. HEMOSTASIS WAS ACHIEVED USING ANOTHER PROGLIDE DEVICE. REPORTEDLY, ON THE OPPOSITE COMMON FEMORAL ARTERY, THE SUTURE BROKE WHEN THE PLUNGER WAS REMOVED DURING A PRECLOSE TECHNIQUE. ANOTHER PROGLIDE WAS DEPLOYED, USING THE PRECLOSE TECHNIQUE, WITH THE SAME RESULTS. TWO ADDITIONAL PROGLIDE DEVICES WERE SUCCESSFULLY DEPLOYED USING THE PRECLOSE TECHNIQUE. THE ARTERIOTOMY WAS UPSIZED TO 22 F AND THE AAA PROCEDURE WAS COMPLETED. AFTER THE PROCEDURE THE SUCCESSFULLY DEPLOYED SUTURES WERE USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. THE PHYSICIAN IS REPORTEDLY TRAINED IN THE USE OF THE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291219 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 30403K1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 7F, 12F, 22F, 24F, HEPARIN