BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2191739 · Received August 4, 2011

    Report

    Report Number
    2024168-2011-05497
    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 FOUND THE SUTURE, LINK, POSTERIOR NEEDLE TIP, AND BOTH CUFFS WERE NOT RETURNED. WITHOUT THE RETURN OF THESE COMPONENTS, THE SCOPE OF THIS INVESTIGATION WAS LIMITED. INSPECTION REVEALED THAT THE ANTERIOR CUFF WAS DETACHED FROM THE NEEDLE TIP DURING THE NEEDLE PLUNGER RETRACTION AS EVIDENCED BY THE DAMAGED ANTERIOR NEEDLE BARB. SUBSEQUENTLY, A FAILURE TO RETRIEVE THE SUTURE OCCURRED 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. CUFF-TO-NEEDLE TIP DETACHMENT SUGGESTED THAT THERE WAS RESISTANCE ENCOUNTERED WHILE RETRACTING THE NEEDLE PLUNGER TO RETRIEVE THE SUTURE. CONTRIBUTING FACTORS CAN INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING DEFICIENCIES, CHALLENGING ANATOMICAL CONDITIONS, AND INCORRECT DEPLOYMENT TECHNIQUES. WITHOUT THE RETURN OF THE SUTURE, LINK, POSTERIOR NEEDLE TIP, AND BOTH CUFFS, NO MANUFACTURING-RELATED DEFICIENCIES COULD BE IDENTIFIED. THERE WAS NO INDICATION THAT THE SUTURE AND/OR LINK MIGHT HAVE BEEN DRAGGED THROUGH THE SUTURE BEARING AREA, WHICH COULD HAVE CAUSED RESISTANCE DURING THE SUTURE RETRIEVAL PROCESS. THE SUTURE BEARING WAS INTACT. THERE WAS NO NEEDLE STRIKE MARK OBSERVED AT THE POSTERIOR FOOT TO SUGGEST THAT THE POSTERIOR NEEDLE MIGHT HAVE BEEN DEFLECTED, STRIKING THE FOOT DURING NEEDLE DEPLOYMENT, RESULTING IN THE POSTERIOR CUFF MISS, WHICH COULD SUBSEQUENTLY CAUSE THE ANTERIOR CUFF TO DETACH FROM ITS NEEDLE TIP. DURING TESTING, THE PLUNGER WAS REINSERTED AND RETRACTED SUCCESSFULLY WITHOUT ANY OBSERVABLE RESISTANCE. EVERY CUFF IS INSPECTED AND TESTED FOR PROPER ASSEMBLY DURING MANUFACTURING. THERE WAS NO INFORMATION REPORTED OR DEFINITIVE EVIDENCE IN THE EVALUATION OF THE RETURNED DEVICE TO SUGGEST THAT THE PLUNGER WAS ABRUPTLY PULLED OUT OF THE DEVICE AFTER NEEDLE DEPLOYMENT WHICH COULD CAUSE THE ANTERIOR CUFF TO DETACH FROM ITS NEEDLE TIP. BASED ON THE REPORTED INFORMATION AND THE INVESTIGATION FINDINGS, THE PROBABLE CAUSE FOR THE ANTERIOR CUFF-TO-NEEDLE TIP DETACHMENT COULD NOT BE DETERMINED. NO MANUFACTURING OR QUALITY DEFICIENCY WAS DETECTED. 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. OVERALL, 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, THIRTY-SIX (36) UNUSED STERILE REPRESENTATIVE SAMPLE DEVICES WITH THE SAME PART AND WITH LOT NUMBER 050186H, 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. (2) PROGLIDE DEVICES, LOT# 040416H AND LOT# 050186H.

    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 ENTIRE PROCEDURE. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. 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 040416H

    Patients

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