BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2191737 · Received August 4, 2011

    Report

    Report Number
    2024168-2011-05496
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 9, 2011
    Report Date
    July 11, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND THAT THE POSTERIOR CUFF MISS OCCURRED DURING THE NEEDLE DEPLOYMENT 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 UNDISTURBED. THIS IS CONSISTENT WITH THE POSTERIOR NEEDLE BEING DEFLECTED AWAY FROM POSTERIOR FOOT DURING NEEDLE DEPLOYMENT INSTEAD OF ENGAGED WITH THE POSTERIOR CUFF INSIDE THE POSTERIOR FOOT POCKET AS INTENDED. 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 ONE ONE-HUNDREDTH (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 POSTERIOR CUFF MISS AND SUBSEQUENT ANTERIOR CUFF-TO-NEEDLE TIP DETACHMENT WOULD RESULT IN A FAILURE TO RETRIEVE THE SUTURE AS REPORTED. BECAUSE THE SUTURE COULD NOT BE RETRIEVED, THE KNOT WOULD NOT FORM TO ADVANCE TO THE ARTERIAL SURFACE TO CLOSE THE VESSEL AS INTENDED. CONTRIBUTING FACTORS FOR NEEDLE DEFLECTION THAT CAN RESULT IN THE POSTERIOR CUFF MISS AND SUBSEQUENT THE ANTERIOR CUFF-TO-NEEDLE TIP DETACHMENT INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING DEFICIENCIES, CHALLENGING ANATOMICAL CONDITIONS, AND INCORRECT DEPLOYMENT TECHNIQUES. THE NEEDLE TRAJECTORY OF EVERY DEVICE IS VERIFIED DURING MANUFACTURING. DURING TESTING, THE PLUNGER WAS REINSERTED 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 DEPLOYMENT TECHNIQUE, BASED ON THE SUCCESSFUL TEST OF THE DEVICES NEEDLE TRAJECTORY AND DURING MANUFACTURING, THE PROBABLE CAUSE FOR THE POSTERIOR CUFF MISS AND SUBSEQUENT ANTERIOR CUFF-TO-NEEDLE TIP DETACHMENT IS NEEDLE DEFLECTION DURING 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 RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT. A QUERY OF THE COMPLAINT DATABASE FOR THIS LOT REVEALED NO SIMILAR INCIDENTS. THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. ADDITIONALLY 36 STERILE, UNUSED DEVICES WERE RETURNED FOR EVALUATION WITH LOT NUMBERS: 050186H, 040416H, 030406H, 040106H, 030266H, 040366H, 040306H, 030126H. FUNCTIONAL TESTING WAS PERFORMED AND ONE DEVICE FROM LOT 040416H WAS FOUND OUT OF SPECIFICATION. THE DETECTED FAILURE WAS THE POSTERIOR CUFF-TO-NEEDLE TIP DETACHMENT DURING THE NEEDLE PLUNGER RETRACTION. THAT UNUSED, STERILE DEVICE IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT.

    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. ADDITIONALLY, (B)(4) UNUSED STERILE REPRESENTATIVE SAMPLE DEVICES WITH THE SAME PART AND LOT NUMBER RELATED TO THIS PRODUCT EXPERIENCE ARE RETURNING FOR EVALUATION; HOWEVER, NOT YET RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. TWO PROGLIDE DEVICES, LOT# 040416H, REFERENCED ARE BEING REPORTED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

    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, NO SUTURES WERE PRESENT WHEN THE DEVICE WAS REMOVED FROM THE PATIENT. A SECOND AND THIRD PROGLIDE DEVICES WERE USED WITH THE SAME RESULTS. HEMOSTASIS WAS ACHIEVED WITH AN NON-ABBOTT DEVICE. A 6FR SHEATH WAS USED DURING INSERTION OF THE DEVICE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. 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 050186H

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention SHEATH: 6F