BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2180546 · Received July 27, 2011

    Report

    Report Number
    2024168-2011-05318
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    June 16, 2011
    Report Date
    July 7, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION FOUND THAT THE DEVICE WAS RETURNED WITHOUT THE SUTURE AND POSTERIOR NEEDLE TIP AND THE RETURNED CONDITION SUBSTANTIATED THE REPORTED PRODUCT EXPERIENCE. INSPECTION REVEALED THAT THE POSTERIOR CUFF MISS OCCURRED DURING NEEDLE DEPLOYMENT AS EVIDENCED BY UNDISTURBED POSTERIOR CUFF TABS. THERE WAS NO NEEDLE STRIKE MARK OBSERVED AT THE POSTERIOR FOOT, SUGGESTING THAT THE POSTERIOR NEEDLE WAS DEFLECTED AWAY FROM POSTERIOR FOOT INSTEAD OF ENGAGED WITH THE POSTERIOR CUFF INSIDE THE POSTERIOR FOOT POCKET DURING THE NEEDLE DEPLOYMENT AS DESIGNED. THE POSTERIOR CUFF MISS WOULD RESULT IN A FAILURE TO RETRIEVE THE SUTURE WHEN RETRACTING THE NEEDLE PLUNGER. BECAUSE THE SUTURE COULD NOT BE RETRIEVED, THE KNOT WOULD NOT FORM TO ADVANCE TO THE ARTERIAL SURFACE TO CLOSE THE VESSEL AS INTENDED. POSSIBLE CONTRIBUTING FACTORS FOR NEEDLE DEFLECTION THAT RESULTED IN THE POSTERIOR CUFF MISS INCLUDED, BUT NOT LIMITED TO, MANUFACTURING DEFICIENCIES, CHALLENGING ANATOMICAL CONDITIONS, AND DEPLOYMENT TECHNIQUES. HOWEVER, THE NEEDLE TRAJECTORY OF EVERY DEVICE IS VERIFIED DURING MANUFACTURING. ALSO, DURING TESTING, THE PLUNGER WAS INSERTED TO TEST THE NEEDLE TRAJECTORY AND PUSH MANDREL TRAVEL AND THE RESULTS MET THE MANUFACTURING CRITERIA. ALTHOUGH, THERE WERE NO CHALLENGING ANATOMICAL CONDITIONS REPORTED OR DEFINITIVE EVIDENCE IN THE EVALUATION OF THE RETURNED DEVICE TO SUGGEST INCORRECT DEVICE DEPLOYMENT TECHNIQUE, BASED ON INVESTIGATION FINDINGS, THE PROBABLE CAUSE FOR THE POSTERIOR CUFF MISS IS NEEDLE DEFLECTION DURING THE PLUNGER DEPLOYMENT DUE TO INTERACTION WITH HUMAN TISSUE OR A FAILURE TO MAINTAIN A STABLE POSITION OF THE DEVICE WITH RESPECT TO THE TISSUE TRACT. NO MANUFACTURING OR QUALITY DEFICIENCY WAS DETECTED AS A RESULT OF THIS INVESTIGATION. 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 COMPLAINT DATABASE FOR THIS LOT REVEALED NO SIMILAR INCIDENTS. OVERALL, 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 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PERCLOSE PROGLIDE DEVICE AFTER A CORONARY DIAGNOSTIC PROCEDURE WHICH USED A 6F SHEATH. REPORTEDLY, A POSTERIOR NEEDLE TO CUFF MISS OCCURRED. A SECOND PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THE PHYSICIAN IS TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE. 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 040306H

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention SHEATH: 6F