BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 4844494 · Received June 15, 2015

    Report

    Report Number
    2024168-2015-03280
    Event Type
    Injury
    Date Received
    June 15, 2015
    Date of Event
    March 11, 2015
    Report Date
    May 13, 2015
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE SUTURE MEDIATED CLOSURE (SMC) SYSTEM WAS RETURNED FOR ANALYSIS. THE REPORTED SUTURE BREAK WAS CONFIRMED. BASED ON A VISUAL/FUNCTIONAL INSPECTION ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. A QUERY/REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE OTHER PERCLOSE PROGLIDE DEVICE, REFERENCED, IS FILED UNDER A SEPARATE MEDWATCH MANUFACTURER REPORT REFERENCE NUMBER.

    Description of Event or Problem · 1

    THE PROGLIDE DEVICE WAS RETURNED WITH NO INFORMATION PROVIDED. THERE WAS NO REPORTED DEVICE ISSUE AND NO REPORTED PATIENT ISSUE. ANALYSIS OF THE RETURNED DEVICE BY ABBOTT VASCULAR REVEALED THE PROGLIDE WAS RETURNED WITH BLOOD IN AND ON THE DEVICE. THE SUTURE WAS PARTIALLY EXPOSED FROM THE GUIDE TUBE. THE PRE-TIED KNOT WAS UNRAVELED. THE SUTURE WAS SEPARATED AT THE SWAGE END OF THE POSTERIOR NEEDLE TIP. A DEVICE IN THIS CONDITION WOULD NOT HAVE ACHIEVED VESSEL CLOSURE OR HEMOSTASIS. THE SITE WAS CONTACTED AND INFORMATION WAS RECEIVED: IT WAS REPORTED THAT SUTURE PLACEMENT IN A COMMON FEMORAL ARTERY WAS ATTEMPTED WITH PROGLIDE DEVICES, USING A PRE-CLOSE TECHNIQUE, VIA A 7F SHEATH PRIOR TO AN ABDOMINAL AORTIC ANEURYSM (AAA) PROCEDURE. REPORTEDLY, THE SUTURE CAME OUT WITH THE DEVICE; A SUTURE BREAK OCCURRED. A SECOND PROGLIDE DEVICE WAS USED WITH THE SAME RESULTS. THE SUTURES OF TWO ADDITIONAL PROGLIDES DEVICES WERE SUCCESSFULLY PREPLACED USING THE PRE-CLOSE TECHNIQUE. THE SHEATH WAS UPSIZED TO 18F AND THE AAA PROCEDURE WAS COMPLETED. HEMOSTASIS WAS ACHIEVED WITH SUCCESSFULLY PREPLACED SUTURES OF THE THIRD AND FOURTH PROGLIDE DEVICES. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. IT WAS REPORTED THAT THE PHYSICIAN IS TRAINED IN THE USE OF THE PROGLIDE DEVICE AND ESTABLISHED IN THE PRE-CLOSE TECHNIQUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388386 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 40125K1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 7F, 18F