BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2231652 · Received September 1, 2011

    Report

    Report Number
    2024168-2011-06083
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    July 28, 2011
    Report Date
    August 17, 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: INVESTIGATION OF THE RETURNED DEVICE INDICATED THAT THE POSTERIOR CUFF-TO-NEEDLE TIP DETACHMENT OCCURRED WHILE RETRACTING THE NEEDLE PLUNGER TO RETRIEVE THE SUTURE AS EVIDENCED BY THE BENT AND FLATTENED POSTERIOR CUFF TABS. CUFF-TO-NEEDLE TIP DETACHMENT WOULD RESULT IN A FAILURE TO RETRIEVE THE SUTURE DURING NEEDLE PLUNGER RETRACTION AND 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. THE POSTERIOR CUFF-TO-NEEDLE TIP DETACHMENT INDICATED THAT THERE WAS RESISTANCE ENCOUNTERED WHILE RETRACTING THE NEEDLE PLUNGER TO RETRIEVE THE SUTURE. POSSIBLE CONTRIBUTING FACTORS INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING, CHALLENGING ANATOMICAL CONDITIONS, AND INCORRECT DEPLOYMENT TECHNIQUES. BECAUSE THE SUTURE WAS NOT RETURNED WITH THE DEVICE, IT COULD NOT BE DETERMINED IF THE SUTURE WAS DRAGGED THROUGH THE DEVICE, WHICH COULD HAVE CAUSED THE POSTERIOR CUFF TO DETACH FROM THE NEEDLE. THERE WAS NO INDICATION THAT THE SUTURE OR LINK WAS DRAGGED THROUGH THE SUTURE BEARING WHILE RETRACTING THE NEEDLE PLUNGER, WHICH COULD HAVE CONTRIBUTED TO CUFF-TO-NEEDLE TIP DETACHMENT. DURING TESTING, THE PLUNGER WAS INSERTED AND RETRACTED SUCCESSFULLY WITHOUT ANY OBSERVABLE RESISTANCE. EVERY CUFF IS INSPECTED AND TESTED FOR PROPER ASSEMBLY DURING MANUFACTURING. THE REPORTED MILD CALCIFICATION AND PRIOR ARTERIOTOMIES IN THE TARGET GROIN COULD HAVE CONTRIBUTED TO RESISTANCE ENCOUNTERED DURING NEEDLE PLUNGER RETRACTION; HOWEVER, THIS COULD NOT BE CONFIRMED. 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 HAVE CAUSED THE POSTERIOR CUFF TO DETACH FROM THE NEEDLE TIP. BASED ON THE REPORTED INFORMATION, MANUFACTURING INSPECTION CRITERIA, AND ANALYSIS OF THE DEVICE, 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 DEVICE HISTORY RECORD FOR THIS LOT 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 RELEVANT INFORMATION. REPORTEDLY, THE PROGLIDE WAS USED IN A MILDLY CALCIFIED VESSEL. PER THE INSTRUCTIONS FOR USE, THE SAFETY AND EFFECTIVENESS OF THE PROGLIDE DEVICE HAVE NOT BEEN ESTABLISHED FOR PATIENTS WITH FEMORAL ARTERY CALCIUM WHICH IS FLUOROSCOPICALLY VISIBLE AT THE ACCESS SITE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF A MILDLY CALCIFIED COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PROGLIDE AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, THE DEVICE WAS DEPLOYED PROPERLY, BUT THE SUTURE BROKE. MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE. A 6FR SHEATH WAS USED. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE ENTIRE PROCEDURE. 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 050056H

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention SHEATH: 6F