BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2171757 · Received July 22, 2011

    Report

    Report Number
    2024168-2011-05076
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    June 29, 2011
    Report Date
    June 29, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: CORRECTION: LOT NUMBER: CORRECTED FROM 040316H TO 020436H. EXPIRATION DATE: CORRECTED FROM 04/30/2013 TO 02/28/2013. DEVICE MANUFACTURE DATE: CORRECTED FROM 04/2011 TO 02/2011. THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED SUTURE RETRIEVAL ISSUE COULD NOT BE CONFIRMED AS THE PLUNGER, SUTURE, LINK, NEEDLES, AND CUFFS WERE NOT RETURNED WITH THE DEVICE LIMITING THE SCOPE OF THE INVESTIGATION. BASED ON THE REPORTED INFORMATION, MANUFACTURING INSPECTION CRITERIA AND ANALYSIS OF THE RETURNED DEVICE, THE PROBABLE CAUSE FOR THE REPORTED SUTURE RETRIEVAL ISSUE COULD NOT BE DETERMINED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH IT WAS INITIALLY REPORTED THE DEVICE WAS DISCARDED AT THE USER FACILITY, THE DEVICE WAS SUBSEQUENTLY RETURNED. EVALUATION SUMMARY: INVESTIGATION OF THE RETURNED DEVICE FOUND THAT THE PLUNGER, SUTURE, LINK, NEEDLES, AND CUFFS WERE NOT RETURNED WITH THE DEVICE. THE SCOPE OF THIS INVESTIGATION WAS VERY LIMITED AND THE REPORTED CUFF MISS/SUTURE RETRIEVAL ISSUE AND ASSOCIATED PATIENT EFFECTS COULD NOT BE CONFIRMED. THERE WAS NO NEEDLE STRIKE MARK AT THE POSTERIOR FOOT TO SUGGEST THAT THE POSTERIOR CUFF MISS MIGHT HAVE OCCURRED DUE TO THE POSTERIOR NEEDLE STRIKING THE FOOT INSTEAD OF ENGAGING WITH THE CUFF INSIDE THE FOOT POCKET DURING NEEDLE DEPLOYMENT. THERE WERE NO ABNORMAL OBSERVATIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED NEEDLE-TO-CUFF MISS. POSSIBLE CONTRIBUTING FACTORS FOR THE REPORTED CUFF MISS/SUTURE RETRIEVAL ISSUE INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING DEFICIENCIES, CHALLENGING ANATOMICAL CONDITIONS, AND/OR INCORRECT DEPLOYMENT TECHNIQUES. DUE TO ALL RELATED COMPONENTS NOT BEING RETURNED WITH THE DEVICE FOR INVESTIGATION, NO MANUFACTURING-RELATED DEFICIENCIES COULD BE IDENTIFIED. THE NEEDLE TRAJECTORY OF EVERY DEVICE IS VERIFIED DURING MANUFACTURING. DURING TESTING, A PROXY PLUNGER WAS INSERTED TO TEST THE NEEDLE TRAJECTORY AND PUSH MANDREL TRAVEL AND THE RESULTS MET THE MANUFACTURING CRITERIA. THERE WERE NO CHALLENGING ANATOMICAL CONDITIONS REPORTED, WHICH COULD HAVE CONTRIBUTED TO THE REPORTED CUFF MISS. THERE WAS NO INFORMATION REPORTED OR DEFINITIVE EVIDENCE IN THE EVALUATION OF THE RETURNED DEVICE TO SUGGEST THAT THE DEVICE MIGHT HAVE BEEN TWISTED AND/OR ROTATED DURING NEEDLE DEPLOYMENT. ALSO, IT COULD NOT BE DEFINITIVELY CONCLUDED THAT THE NEEDLES WERE DEPLOYED WHEN THE DEVICE WAS AT AN APPROXIMATE 45 DEGREE ANGLE, WHICH COULD HAVE CONTRIBUTED TO THE REPORTED CUFF MISS. BASED ON THE REPORTED INFORMATION, THE MANUFACTURING INSPECTION CRITERIA, AND ANALYSIS OF THE RETURNED DEVICE, THE PROBABLE CAUSE FOR THE REPORTED CUFF MISS COULD NOT BE DETERMINED. NO MANUFACTURING OR QUALITY DEFICIENCY WAS DETECTED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR ANALYSIS. WITHOUT THE DEVICE EVALUATION, A CAUSE FOR THE SUTURE RETRIEVAL PROBLEM COULD NOT BE DETERMINED. A CUFF-MISS (SUTURE NOT RETRIEVED) 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 A CHALLENGING ANATOMY, AGGRESSIVELY DEPLOYING OR REMOVING THE PLUNGER AND/OR INADEQUATE POSITIONING OF THE FOOT AGAINST THE ARTERIAL WALL. WHETHER THESE CONDITIONS PLAYED A ROLE IN THE EXPERIENCED EVENT CANNOT BE VERIFIED. TO ENSURE THIS TYPE OF EXPERIENCE IS NOT A RESULT OF A POTENTIAL PRODUCT RELATED DEFICIENCY, THE NEEDLE TRAJECTORY OF EVERY DEVICE IS CHECKED TWICE DURING MANUFACTURING. IN ADDITION, A SAMPLING OF FINISHED DEVICES IS ALSO TESTED TO VERIFY THE FUNCTIONALITY OF THE DEVICE. A REVIEW OF THE PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. IN ADDITION, 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. BASED ON THE INFORMATION AVAILABLE, AND THE INSPECTION, THERE DOES NOT APPEAR TO BE ANY INDICATIONS OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WAS ATTEMPTED USING THE PERCLOSE PROGLIDE DEVICE AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, WHILE PULLING BACK THE PLUNGER, THE SUTURE WAS NOT RETRIEVED. A NON-ABBOTT DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA. REPORTEDLY, THE PHYSICIAN IS TRAINED IN THE USE OF THE DEVICE. 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 020436H

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention SHEATH: 6F CORDISOTHER: HEPARIN