BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2162098 · Received July 14, 2011

    Report

    Report Number
    2024168-2011-04959
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 24, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. THE SAFETY AND EFFECTIVENESS OF THE PERCLOSE PROGLIDE DEVICE HAS NOT BEEN ESTABLISHED IN PATIENTS WITH FEMORAL ARTERY CALCIUM WHICH IS FLUOROSCOPICALLY VISIBLE AT ACCESS SITE. THE FIRST PROGLIDE IS BEING FILED UNDER A SEPARATE MANUFACTURER REPORT NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE NOTED THAT BOTH CUFFS WERE CAPTURED AND ATTACHED TO THE NEEDLE TIPS, THE SUTURE HAD BEEN CUT APPROXIMATELY 1 CM DISTAL OF THE POSTERIOR NEEDLE TIP. BASED ON THESE FINDINGS THE NEEDLE TO CUFF MISS REPORTED DID NOT OCCUR. THE SUTURE HAD BEEN HARVESTED. IT WAS NOTED DURING THE ANALYSIS THAT THE GUIDE TUBE WAS BENT. THE BEND IN THE METAL GUIDE TUBE IS CONSISTENT WITH DAMAGE DURING THE DENOMINATION PROCESS AND NOT RELATED TO THE REPORTED EVENT. A CUFF-MISS CAN BE INFLUENCED BY FACTORS THAT INCLUDE, BUT ARE NOT LIMITED TO: MANUFACTURING, USER TECHNIQUE BY FAILING TO POSITION AND MAINTAIN THE DEVICE AT A 45 DEGREE ANGLE THROUGHOUT DEPLOYMENT, ROTATING THE DEVICE AT ANY POINT DURING PLUNGER/NEEDLE DEPLOYMENT, DEPLOYING THE DEVICE IN CHALLENGING ANATOMIES (E.G. HEAVY CALCIFIED ARTERIES, MORBIDLY OBESE PATIENTS, ETC.), AGGRESSIVELY DEPLOYING THE PLUNGER OR AGGRESSIVELY REMOVING THE PLUNGER OR FAILING TO MAINTAIN ADEQUATE FOOT POSITION AGAINST THE ARTERIAL WALL. THE REPORTED CALCIFICATION INDICATE THE PATIENT ANATOMICAL CONDITION MAY HAVE BEEN A CONTRIBUTING FACTOR, HOWEVER BASED ON THE ANALYSIS THIS CAN NOT BE CONCLUSIVELY DETERMINED. BECAUSE THE ANALYSIS OF THE RETURNED DEVICE FOUND NO INDICATION OF A PRODUCT QUALITY DEFICIENCY, IT IS NOT BELIEVED THAT THIS EVENT IS RELATED TO A MANUFACTURING ISSUE. THE REPORTED NEEDLE TO CUFF MISS EXPERIENCE COULD NOT BE CONFIRMED AND A DEFINITIVE CAUSE COULD HAVE NOT BEEN DETERMINED. TO HELP ENSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT TO AN INSPECTION DURING MANUFACTURING. THE NEEDLE TRAJECTORY OF EACH DEVICE IS INSPECTED TWICE DURING MANUFACTURING. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD (LHR) FOR THE REPORTED LOT REVEALED NO NONCONFORMING MATERIAL RECORD (NCMR) THAT WOULD HAVE CONTRIBUTED TO THE REPORTED NEEDLE TO CUFF MISS IN THIS CASE. FOUR STERILE /UNUSED DEVICES FROM THE SAME LOT NUMBER THAN THIS INVOLVED INCIDENT WERE RETURNED FOR EVALUATION. ALL THE DEVICES WERE TESTED AND THEY PERFORMED ACCORDING TO SPECIFICATIONS, THERE WAS NO PRODUCT QUALITY DEFICIENCY NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ARTERIOTOMY CLOSURE OF A MODERATELY CALCIFIED COMMON FEMORAL ARTERY (CFA) WAS ATTEMPTED USING A PROGLIDE DEVICE AFTER AN INTERVENTIONAL CATH PROCEDURE. REPORTEDLY, THE PHYSICIAN PULLED THE NEEDLES RIGHT OUT OF THE DEVICE; RETRIEVED THE PLUNGER AND THE SUTURE WAS NOT PRESENT. ANOTHER PROGLIDE WAS ATTEMPTED WITH THE SAME RESULT. HEMOSTASIS WAS ACHIEVED USING MANUAL ARTERIAL COMPRESSION. IT WAS INDICATED THAT THE PATIENT STAYED LONGER IN THE HOSPITAL BECAUSE OF MEDICATION, AND THE ACCESS SITE CLOSURE EVENT DID NOT CONTRIBUTE TO THE DELAYED HOSPITALIZATION. THERE WERE NO ADVERSE PATIENT EFFECTS RELATED TO THE ATTEMPTED VESSEL CLOSURE. 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 030046H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention