BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2130460 · Received June 16, 2011

    Report

    Report Number
    2024168-2011-04238
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 25, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE WHOLE SUTURE WAS RETURNED OUTSIDE THE DEVICE UNDAMAGED. THE KNOT WAS UNRAVELED. THE PLUNGER AND ITS ANTERIOR NEEDLE WERE NOT RETURNED. INSPECTION OF THE RETURNED DEVICE INDICATED THAT BOTH CUFFS SUCCESSFULLY CAPTURED THE NEEDLES DURING THE NEEDLE PLUNGER DEPLOYMENT; HOWEVER, DURING THE NEEDLE PLUNGER RETRACTION, THE ANTERIOR CUFF WAS DETACHED FROM ITS NEEDLE AS EVIDENCED BY DAMAGED ANTERIOR CUFF TABS. ONE OF THE ANTERIOR CUFF TABS (MEASURING APPROX. 0.01 BY 0.01 INCHES) WAS BROKEN OFF AND WAS NOT RETURNED WITH THE DEVICE. THE ANTERIOR CUFF DETACHMENT COULD APPEAR VERY SIMILAR TO THE REPORTED ANTERIOR CUFF MISS. CUFF-TO-NEEDLE TIP DETACHMENT WOULD RESULT IN A FAILURE TO RETRIEVE THE SUTURE, FORM THE KNOT, AND ADVANCE THE KNOT 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 ANTERIOR CUFF-TO-NEEDLE TIP DETACHMENT DURING THE SUTURE RETRIEVAL PROCESS INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING DEFICIENCY, ANATOMICAL CONDITIONS, AND DEPLOYMENT TECHNIQUE. NO MANUFACTURING OR QUALITY DEFICIENCY WAS DETECTED. THE SUTURE WAS RETURNED INTACT. THERE WAS NO INDICATION THAT THE SUTURE WAS DRAGGED THROUGH THE SUTURE BEARING AREA OR THE DEVICE WHILE RETRACTING THE NEEDLE PLUNGER WHICH COULD CONTRIBUTE TO CUFF-TO-NEEDLE TIP DETACHMENT. ALSO, THERE WAS NO INDICATION THAT THE SUTURE KNOT MIGHT HAVE BEEN INCORRECTLY ASSEMBLED WHICH COULD CAPTURE THE ANTERIOR CUFF AND CAUSE THE CUFF TO DETACH FROM ITS NEEDLE TIP. DURING LAB TESTING, THE PROXY PLUNGER WAS INSERTED AND RETRACTED SUCCESSFULLY WITHOUT ANY OBSERVABLE RESISTANCE. THERE WERE NO REPORTED CHALLENGING ANATOMICAL CONDITIONS WHICH COULD CREATE RESISTANCE TO RETRACTING THE NEEDLE PLUNGER AND CAUSE THE ANTERIOR CUFF TO DETACH FROM ITS NEEDLE TIP. THERE WAS NO INFORMATION REPORTED OR DEFINITIVE EVIDENCE IN THE EVALUATION OF THE RETURNED DEVICE THAT SUGGEST INCORRECT TECHNIQUE. THERE WAS NO INDICATION THAT THE NEEDLE PLUNGER WAS ABRUPTLY PULLED OUT OF THE DEVICE AFTER NEEDLE DEPLOYMENT WHICH COULD CAUSE THE ANTERIOR CUFF TO DETACH FROM ITS NEEDLE TIP. A QUERY OF THE COMPLAINT DATABASE FOR THIS LOT BASED ON ACTUAL INVESTIGATION FINDINGS REVEALED NO OTHER INCIDENTS THAT EXHIBITED THE ANTERIOR CUFF DETACHMENT AS THIS INCIDENT. A REVIEW OF THE PRODUCT LOT HISTORY RECORD (LHR) PRODUCED NO FINDINGS RELEVANT TO THIS EVENT. BASED ON THE REPORTED INFORMATION AND DEVICE INVESTIGATION, THE PROBABLE CAUSE FOR THE ANTERIOR CUFF-TO-NEEDLE TIP DETACHMENT COULD NOT BE DETERMINED. THERE DOES NOT APPEAR TO BE ANY INDICATIONS OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF A COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, THE PROGLIDE DEVICE WAS ADVANCED UNTIL PULSATILE FLOW WAS ACHIEVED, THE LEVER WAS LIFTED, THE DEVICE RETRACTED AND THE PLUNGER WAS DEPRESSED UNTIL THE COLLAR MET THE DEVICE BODY. WHEN THE PLUNGER WAS WITHDRAWN AN ANTERIOR CUFF MISS HAD OCCURRED. HEMOSTASIS WAS ACHIEVED USING A NON-ABBOTT 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 020196H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention