BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2122252 · Received June 13, 2011

    Report

    Report Number
    2024168-2011-04140
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 19, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL ADDITIONAL, RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE DEVICE FOUND THAT IT WAS RETURNED WITH THE PLUNGER, SUTURE, NEEDLES, AND CUFFS IN THE PRE-DEPLOYED POSITION. DRIED BLOOD WAS OBSERVED THROUGHOUT THE DEVICE, INDICATING THE DEVICE WAS INTRODUCED INTO THE PATIENT ANATOMY. THE LINK WAS SLACK, INDICATING THE FOOT HAD BEEN DEPLOYED; HOWEVER, DURING TESTING, THE LUMINAL MARKING TEST WAS PERFORMED AND THE MARKER LUMEN WAS NOT PATENT AS REPORTED. DURING TESTING, NEEDLE DEPLOYMENT AND SUTURE RETRIEVAL WERE SUCCESSFUL AS INTENDED. THE DEVICE WAS DISASSEMBLED AND THE INTERNAL INSPECTION FOUND DRIED BLOOD OR OTHER BIOLOGICAL MATTERS OCCLUDING THE MARKER LUMEN. POSSIBLE CONTRIBUTING FACTORS FOR THE OCCLUDED MARKER LUMEN INCLUDED MANUFACTURING DEFICIENCIES, CHALLENGING ANATOMICAL CONDITIONS, AND DEPLOYMENT TECHNIQUES. THE MARKER LUMEN PATENCY TEST IS PERFORMED ON EVERY DEVICE DURING MANUFACTURING. THERE WERE NO CHALLENGING ANATOMICAL CONDITIONS REPORTED. THERE WAS NO INFORMATION REPORTED OR DEFINITIVE EVIDENCE IN THE EVALUATION OF THE RETURNED DEVICE TO SUGGEST THAT THE DEVICE WAS INSERTED INTO THE PATIENT ANATOMY AT AN ANGLE GREATER THAN 45 DEGREES WHICH COULD HAVE CONTRIBUTED TO POOR OR NO LUMINAL MARKING. BASED ON THE INVESTIGATION FINDINGS, AND THE CASE INFORMATION, THE PROBABLE CAUSE FOR THE MARKER LUMEN BLOCKAGE IS DUE TO A BLOOD CLOT OR OTHER BIOLOGICAL MATTERS. NO MANUFACTURING OR QUALITY DEFICIENCY WAS DETECTED. OVERALL, THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY RELEVANT NONCONFORMING MATERIAL RECORDS FOR THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. A QUERY OF THE DATABASE FOR THIS LOT REVEALED NO SIMILAR INCIDENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE, DURING A PRECLOSE TECHNIQUE, OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, DURING DEVICE INSERTION, LIGHT PULSATILE FLOW WAS OBSERVED AT THE MARKER LUMEN. THE DEVICE WAS REMOVED, FLUSHED AND RE-INSERTED. THERE WAS NO BLOOD FLOW AT THE MARKER LUMEN. THE DEVICE WAS REMOVED AND A SECOND PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT 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 870016H

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention HEPARIN