BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2130266 · Received June 16, 2011

    Report

    Report Number
    2024168-2011-04226
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 24, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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 RELEVANT INFORMATION. THE SECOND PROGLIDE IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: INVESTIGATION OF THE RETURNED DEVICE FOUND THAT THE SUTURE, POSTERIOR CUFF, AND POSTERIOR NEEDLE TIP WERE NOT RETURNED. THE SCOPE OF THIS INVESTIGATION WAS LIMITED. THE INSPECTION REVEALED A LINK BREAK AT THE SWAGE END OF THE POSTERIOR CUFF WHILE RETRACTING THE NEEDLE PLUNGER, WHICH SUBSEQUENTLY RESULTED IN A FAILURE TO RETRIEVE THE SUTURE AND COULD APPEAR VERY SIMILAR TO THE REPORTED CUFF MISS. A LINK BREAK SUGGESTED THAT THERE WAS RESISTANCE ENCOUNTERED WHILE RETRACTING THE NEEDLE PLUNGER TO RETRIEVE THE SUTURE. CONTRIBUTING FACTORS FOR THE LINK BREAK DURING THE SUTURE RETRIEVAL PROCESS INCLUDES, BUT IS NOT LIMITED TO MANUFACTURING DEFICIENCIES, ANATOMICAL CONDITIONS OR DEPLOYMENT TECHNIQUE. THE SUTURE WAS NOT RETURNED; THEREFORE, IT COULD NOT BE DETERMINED IF THERE WERE DAMAGES RELATED TO MANUFACTURING THAT COULD CAUSE THE SUTURE TO DRAG THROUGH THE DEVICE WHILE RETRACTING THE NEEDLE PLUNGER. DURING MANUFACTURING, EVERY SUTURE IS APPROPRIATELY ASSEMBLED AND LOADED INTO THE DEVICE AND EVERY LINK ASSEMBLY IS APPROPRIATELY ASSEMBLED, INSPECTED, AND TESTED. THE WERE NO DAMAGES OBSERVED AT THE SUTURE BEARING TO SUGGEST THAT THE SUTURE OR LINK WAS DRAGGED THROUGH THE SUTURE BEARING WHICH COULD CAUSE THE LINK TO BREAK. DURING TESTING, THE PLUNGER WAS INSERTED AND RETRACTED SUCCESSFULLY WITHOUT ANY OBSERVABLE RESISTANCE. THE REPORTED ARTERIAL CALCIFICATION COULD CONTRIBUTE TO THE DETECTED LINK BREAK; HOWEVER, THIS COULD NOT BE CONFIRMED. THE INSTRUCTIONS FOR USE, UNDER THE SPECIAL PATIENT POPULATIONS SECTION, STATES: THE SAFETY AND EFFECTIVENESS OF THE PERCLOSE PROGLIDE SMC DEVICES HAVE NOT BEEN ESTABLISHED IN PATIENTS WITH FEMORAL ARTERY CALCIUM WHICH IS FLUOROSCOPICALLY VISIBLE AT ACCESS SITE. THERE WAS NO INFORMATION REPORTED OR DEFINITIVE EVIDENCE IN THE EVALUATION OF THE DEVICE THAT SUGGESTED INCORRECT TECHNIQUE. THERE WAS NO INDICATION THAT THE NEEDLE PLUNGER WAS ABRUPTLY PULLED OUT OF THE DEVICE AFTER NEEDLE DEPLOYMENT, WHICH COULD CAUSE THE LINK TO DETACH AT THE ANTERIOR CUFF. THERE WAS NO NEEDLE STRIKE MARK AT THE POSTERIOR FOOT TO INDICATE THAT THE POSTERIOR NEEDLE HAD STRUCK THE FOOT DURING THE NEEDLE DEPLOYMENT, RESULTING IN THE POSTERIOR CUFF MISS, WHICH WOULD SUBSEQUENTLY RESULT IN THE LINK-TO-CUFF DETACHMENT WHILE RETRACTING THE NEEDLE PLUNGER. BASED ON THE INVESTIGATION FINDINGS, THE PROBABLE CAUSE FOR THE LINK BREAK AT THE SWAGE END OF THE POSTERIOR CUFF COULD NOT BE DETERMINED. NO MANUFACTURING OR QUALITY ISSUES WERE DETECTED. A REVIEW OF THE PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS THAT AFFECTED THIS LOT. A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY FOR THE ACTUAL INVESTIGATION FINDINGS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF A MILDLY CALCIFIED COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED. A SECOND PROGLIDE DEVICE WAS USED WITH THE SAME RESULTS. MANUAL ARTERIAL COMPRESSION WAS APPLIED 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 040036H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention