BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2162453 · Received July 14, 2011

    Report

    Report Number
    2024168-2011-04963
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 23, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE WHOLE SUTURE WAS RETURNED UNDAMAGED AND PARTIALLY EXPOSED; THE KNOT WAS FORMED. INVESTIGATION OF THE RETURNED DEVICE INDICATED THAT BOTH CUFFS SUCCESSFULLY CAPTURED THE NEEDLES AND THE RAIL SUTURE END WAS CUT WITH THE DEVICE CUTTER. THIS IS CONSISTENT WITH SUCCESSFUL NEEDLE DEPLOYMENT AND SUTURE RETRIEVAL. THE SUTURE KNOT WAS PROPERLY FORMED, BUT THE LOOP REMAINED IN THE SUTURE BEARING. DURING TESTING, THE SUTURE BEARING WAS INSPECTED AND THERE WAS NO OBSTRUCTION THAT COULD PREVENT THE SUTURE LOOP FROM BEING RELEASED FROM THE SUTURE BEARING. THERE WERE NO ABNORMAL OBSERVATIONS THAT COULD CONTRIBUTE TO THE REPORTED DIFFICULTY OF REMOVING THE DEVICE AS THE FOOT WAS ABLE TO BE DEPLOYED AND PARKED AS DESIGNED. BASED ON THE INVESTIGATION FINDINGS, THE REPORTED DIFFICULT DEVICE REMOVAL COULD NOT BE CONFIRMED. THE PROBABLE CAUSE FOR THE FAILURE TO RELEASE THE SUTURE LOOP FROM THE SUTURE BEARING IS DEPLOYMENT OF THE DEVICE OUTSIDE THE ARTERY, RESULTING IN THE SUTURE WITH THE KNOT BEING REMOVED ALONG WITH THE DEVICE; THEREFORE, THE KNOT COULD NOT BE ADVANCED TO THE ARTERIAL SURFACE TO CLOSE THE VESSEL AS DESIGNED. SUBSEQUENTLY, HEMORRHAGE WOULD OCCUR. THE PROBABLE CAUSE FOR THE DETECTED FAILURE TO RELEASE THE SUTURE LOOP FROM THE SUTURE BEARING WAS DETERMINED TO BE RELATED TO THE OPERATIONAL CONTEXT DURING USE OF THE DEVICE AND NOT A PRODUCT QUALITY DEFICIENCY. EVERY SUTURE IS APPROPRIATELY ASSEMBLED AND LOADED INTO THE DEVICE. NO MANUFACTURING OR QUALITY DEFICIENCY WAS DETECTED. A QUERY OF THE COMPLAINT DATABASE FOR THIS LOT REVEALED NO OTHER INCIDENTS WITH THE REPORTED DIFFICULT DEVICE REMOVAL AND 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 NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PERCLOSE PROGLIDE AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AFTER SUCCESSFULLY CLOSING THE LEFT GROIN WITH A PROGLIDE DEVICE, THE RIGHT COMMON FEMORAL ARTERY WAS TO BE CLOSED WITH ANOTHER PROGLIDE. HOWEVER, AT AN UNSPECIFIED POINT OF THE CLOSING PROCEDURE, THE DEVICE COULD NOT BE REMOVED. AN UNSUCCESSFUL ATTEMPT TO MOVE THE LEVER WAS MADE TO RELEASE THE DEVICE; HOWEVER, AFTER FURTHER MANIPULATION, THE DEVICE WAS SUCCESSFULLY REMOVED. MANUAL ARTERIAL COMPRESSION AND A NON-ABBOTT DEVICE WERE USE TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA. UPON EXAMINATION OF THE DEVICE, THE SUTURE WITH THE KNOT COULD BE SEEN. REPORTEDLY, THE PHYSICIAN IS PROFICIENT IN THE USE OF THE DEVICE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDE.

    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 040306H

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention SHEATH: 7FHEPARIN