BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2180402 · Received July 27, 2011

    Report

    Report Number
    2024168-2011-05323
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 8, 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: THE RETURNED PLUNGER ASSEMBLY REVEALED THAT BOTH CUFFS CAPTURED THE NEEDLES AND THE RAIL SUTURE END WAS CUT. THIS IS INDICATIVE OF SUCCESSFUL NEEDLE DEPLOYMENT AND SUTURE RETRIEVAL; THEREFORE, DOES NOT MATCHED THE REPORTED EVENT. INVESTIGATION OF THE RETURNED DEVICE REVEALED THAT THE POSTERIOR CUFF WAS DETACHED FROM THE NEEDLE TIP DURING THE NEEDLE PLUNGER RETRACTION AS EVIDENCED BY THE DAMAGED POSTERIOR NEEDLE BARB. SUBSEQUENTLY, A FAILURE TO RETRIEVE THE SUTURE OCCURRED, WHICH COULD APPEAR VERY SIMILAR TO THE REPORTED SUTURE BREAK. 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. POSSIBLE CONTRIBUTING FACTORS FOR THE POSTERIOR CUFF-TO-NEEDLE TIP DETACHMENT DURING THE SUTURE RETRIEVAL PROCESS CAN INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING DEFICIENCIES, CHALLENGING ANATOMICAL CONDITIONS, AND INCORRECT DEPLOYMENT TECHNIQUES. THE SUTURE AND SUTURE BEARING WERE INTACT. THERE WAS NO INDICATION THAT THE SUTURE WAS DRAGGED THROUGH THE DEVICE OR SUTURE BEARING DURING THE NEEDLE PLUNGER RETRACTION, WHICH COULD HAVE CONTRIBUTED TO THE POSTERIOR CUFF-TO-NEEDLE TIP DETACHMENT. DURING TESTING, A PROXY PLUNGER WAS INSERTED AND RETRACTED SUCCESSFULLY WITHOUT ANY OBSERVABLE RESISTANCE. EVERY CUFF IS INSPECTED AND TESTED FOR PROPER ASSEMBLY DURING MANUFACTURING. THERE WERE NO CHALLENGING ANATOMICAL CONDITIONS REPORTED, WHICH COULD HAVE CAUSED THE POSTERIOR CUFF TO DETACH FROM THE NEEDLE TIP. THERE WAS NO INFORMATION REPORTED OR DEFINITIVE EVIDENCE IN THE EVALUATION OF THE DEVICE TO SUGGEST THAT THE PLUNGER WAS ABRUPTLY PULLED OUT OF THE DEVICE AFTER NEEDLE DEPLOYMENT, WHICH COULD HAVE CAUSED THE POSTERIOR CUFF TO DETACH. BASED ON THE REPORTED INFORMATION AND THE INVESTIGATION FINDINGS, THE PROBABLE CAUSE FOR THE POSTERIOR CUFF-TO-NEEDLE TIP DETACHMENT COULD NOT BE DETERMINED. NO MANUFACTURING OR QUALITY DEFICIENCY WAS DETECTED. REVIEW OF THE LOT HISTORY RECORD FOR DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. A QUERY OF THE COMPLAINT-HANDLING DATABASE FOR THIS LOT REVEALED NO 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 ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED ARTERIOTOMY CLOSURE USING A PROGLIDE DEVICE WITH A 6FR SHEATH IN THE LEFT COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, WHEN THE PLUNGER WAS REMOVED A SUTURE BREAK OCCURRED. THE VESSEL WAS RE-WIRED AND A SECOND PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. REPORTEDLY THE PHYSICIAN IS TRAINED IN THE USE OF THE PROGLIDE 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 050096H

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention 6 FR SHEATH