BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2024217 · Received March 18, 2011

    Report

    Report Number
    2024168-2011-01838
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 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
    RI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE INDICATED THAT THE POSTERIOR CUFF MISS OCCURRED AS EVIDENCED BY THE POSTERIOR CUFF REMAINING IN THE FOOT POCKET. THE POSTERIOR NEEDLE TIP WAS RELEASED FROM THE SHANK BUT DID NOT ENGAGE WITH THE POSTERIOR CUFF AND REMAINED UNDAMAGED. BECAUSE THE POSTERIOR NEEDLE DID NOT ENGAGE WITH THE POSTERIOR CUFF, THE CUFF WAS NOT EJECTED FROM THE FOOT. WHEN THE PLUNGER WAS REMOVED FROM THE DEVICE, THE LINK WAS HELD ON ONE END BY THE POSTERIOR CUFF IN THE FOOT POCKET WHILE BEING PULLED ON THE OTHER END BY THE WITHDRAWAL OF THE PLUNGER. THIS RESULTED IN THE ANTERIOR CUFF DETACHING FROM THE NEEDLE AS INDICATED BY DAMAGED ANTERIOR CUFF TABS. ONE OF THE ANTERIOR CUFF TABS WAS BROKEN OFF AND WAS NOT RETURNED WITH THE DEVICE. CUFF TABS MEASURE ON ONE-HUNDRETH (0.01) OF AN INCH SQUARE. DUE TO THE EXTREMELY SMALL SIZE, A MISSING CUFF TAB IS NOT VISIBLE WITHOUT MAGNIFICATION AND WOULD NOT BE NOTED BY THE USER. THE RETURNED PLUNGER WAS UNMATCHED WITH THE RETURNED DEVICE AS IT REVEALED THAT BOTH CUFFS SUCCESSFULLY CAPTURED THE NEEDLES. DURING TESTING, THE PROXY PLUNGER WAS INSERTED TO TEST THE NEEDLE TRAJECTORY AND PUSH MANDREL TRAVEL LENGTH AND THE RESULTS MET THE MANUFACTURING CRITERIA. BASED ON THE INVESTIGATION FINDINGS, THE PROBABLE CAUSE FOR THE POSTERIOR CUFF MISS AND SUBSEQUENT ANTERIOR CUFF-TO-NEEDLE TIP DETACHMENT IS NEEDLE DEFLECTION 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 ISSUE WAS DETECTED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: A CORRECTION WAS MADE IN ONE PARAGRAPH IN THE DEVICE EVALUATION INCLUDED IN THE MEDWATCH REPORT FOLLOW-UP #1, WHICH READ AS FOLLOWS: THE RETURNED PLUNGER WAS UNMATCHED WITH THE RETURNED DEVICE AS IT REVEALED THAT BOTH CUFFS SUCCESSFULLY CAPTURED THE NEEDLES. THE STATEMENT SHOULD HAVE INDICATED: THE RETURNED PLUNGER WAS UNMATCHED WITH THE RETURNED DEVICE AS IT REVEALED THAT THE ANTERIOR CUFF SUCCESSFULLY CAPTURED THE ANTERIOR NEEDLE AND THE POSTERIOR CUFF WAS ATTACHED TO THE LINK AND PLUNGER ASSEMBLY WITH ITS TABS BEING UNTOUCHED. FOR CONTEXTUAL PURPOSES THE ENTIRE DEVICE EVALUATION SUMMARY WITH THE CORRECTION IS PROVIDED BELOW: EVALUATION OF THE RETURNED DEVICE INDICATED THAT THE POSTERIOR CUFF MISS OCCURRED AS EVIDENCED BY THE POSTERIOR CUFF REMAINING IN THE FOOT POCKET. THE POSTERIOR NEEDLE TIP WAS RELEASED FROM THE SHANK BUT DID NOT ENGAGE WITH THE POSTERIOR CUFF AND REMAINED UNDAMAGED. BECAUSE THE POSTERIOR NEEDLE DID NOT ENGAGE WITH THE POSTERIOR CUFF, THE CUFF WAS NOT EJECTED FROM THE FOOT. WHEN THE PLUNGER WAS REMOVED FROM THE DEVICE, THE LINK WAS HELD ON ONE END BY THE POSTERIOR CUFF IN THE FOOT POCKET WHILE BEING PULLED ON THE OTHER END BY THE WITHDRAWAL OF THE PLUNGER. THIS RESULTED IN THE ANTERIOR CUFF DETACHING FROM THE NEEDLE AS INDICATED BY DAMAGED ANTERIOR CUFF TABS. ONE OF THE ANTERIOR CUFF TABS WAS BROKEN OFF AND WAS NOT RETURNED WITH THE DEVICE. CUFF TABS MEASURE ON ONE-HUNDRETH (0.01) OF AN INCH SQUARE. DUE TO THE EXTREMELY SMALL SIZE, A MISSING CUFF TAB IS NOT VISIBLE WITHOUT MAGNIFICATION AND WOULD NOT BE NOTED BY THE USER. THE RETURNED PLUNGER WAS UNMATCHED WITH THE RETURNED DEVICE AS IT REVEALED THAT BOTH CUFFS SUCCESSFULLY CAPTURED THE NEEDLES. DURING TESTING, THE PROXY PLUNGER WAS INSERTED TO TEST THE NEEDLE TRAJECTORY AND PUSH MANDREL TRAVEL LENGTH AND THE RESULTS MET THE MANUFACTURING CRITERIA. BASED ON THE INVESTIGATION FINDINGS, THE PROBABLE CAUSE FOR THE POSTERIOR CUFF MISS AND SUBSEQUENT ANTERIOR CUFF-TO-NEEDLE TIP DETACHMENT IS NEEDLE DEFLECTION 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 ISSUE WAS DETECTED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(6). 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 A PHYSICIAN, TRAINED IN THE USE OF THE PROGLIDE DEVICE, ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED AND A SECOND PROGLIDE WAS USED TO ACHIEVE HEMOSTASIS. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECT. 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 960206H

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention