BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2131720 · Received June 16, 2011

    Report

    Report Number
    2024168-2011-04264
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 26, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION FOUND THAT THE DEVICE WAS RETURNED PARTIALLY DEPLOYED WITHOUT THE PLUNGER, ANTERIOR NEEDLE TIP AND SUTURE. THE ANTERIOR CUFF HAD DETACHED FROM THE NEEDLE TIP, ONE OF THE ANTERIOR CUFF TABS WAS BROKEN OFF AND WAS NOT RETURNED WITH THE DEVICE. CUFF TABS MEASURE ONE ONE-HUNDREDTH (0.01) OF AN INCH SQUARE. DUE TO THE EXTREMELY SMALL SIZE, A MISSING CUFF TAB IS NOT VISIBLE WITHOUT MAGNIFICATION AND WOULD NOT BE NOTED BY THE USER. THE POSTERIOR CUFF WITH A PORTION OF THE RAIL SUTURE REMAINED IN THE FOOT POCKET. THE POSTERIOR CUFF NOT EJECTING FROM THE CUFF DURING NEEDLE DEPLOYMENT, CREATED A MISS CONDITION AS EVIDENCED BY THE POSTERIOR CUFF REMAINING IN THE FOOT POCKET. THE SUTURE MOSTLY LIKELY WAS BROKEN POST PROCEDURE AS THE SUTURE WAS REMOVED FROM THE DEVICE, BECAUSE THE NEEDLE TIP AND CUFF WERE NOT EJECTED FROM THE FOOT. WHEN THE PLUNGER WAS REMOVED FROM THE DEVICE, THE LINK WAS HELD ON ONE END BY THE POSTERIOR CUFF IN THE FOOT POCKET WHILE BEING PULLED ON THE OTHER END BY THE WITHDRAWAL OF THE PLUNGER. THIS RESULTED IN THE ANTERIOR CUFF DETACHING FROM THE NEEDLE. A PROXY PLUNGER WAS INSERTED TO TEST THE NEEDLE TRAJECTORY AND THE RESULTS WERE ACCEPTABLE. THE NEEDLE TRAJECTORY OF EACH DEVICE IS INSPECTED DURING MANUFACTURING. A CUFF-MISS OR PARTIAL DEPLOYMENT IN THIS CASE CAN BE INFLUENCED BY MANY FACTORS, INCLUDING, BUT NOT LIMITED TO; MANUFACTURING, FAILURE TO POSITION AND MAINTAIN THE DEVICE AT A 45-DEGREE ANGLE THROUGHOUT DEPLOYMENT, ROTATING THE DEVICE AT ANY POINT DURING PLUNGER/NEEDLE DEPLOYMENT, DEPLOYMENT IN CHALLENGING ANATOMIES (E.G. HEAVY CALCIFIED ARTERIES, MORBIDLY OBESE PATIENTS, ETC.), AGGRESSIVELY DEPLOYING OR REMOVING THE PLUNGER AND/OR INADEQUATE POSITIONING OF THE FOOT AGAINST THE ARTERIAL WALL. BASED ON THE INVESTIGATION FINDINGS, THE POSTERIOR CUFF MISS EXPERIENCED DURING THE PROCEDURE APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT. THERE DOES NOT APPEAR TO BE ANY INDICATIONS OF A PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. NO MANUFACTURING OR QUALITY INSPECTION DEFICIENCY WAS DETECTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TECHNICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AFTER THE DEVICE WAS DEPLOYED AND THE PLUNGER WAS REMOVED NO SUTURES WERE ATTACHED TO THE NEEDLES. A SECOND PROGLIDE WAS USED WITH THE SAME RESULTS. A THIRD PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. 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 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 950266H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention HEPARIN