BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2060288 · Received April 15, 2011

    Report

    Report Number
    2024168-2011-02679
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 23, 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, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE ANALYSIS OF THE RETURNED COMPONENTS FOUND THE DEVICE WAS FULLY DEPLOYED WITH BLOOD PRESENT IN THE DEVICE. BOTH CUFFS HAD BEEN CAPTURED AND THE SUTURE HAD BEEN CUT DISTAL OF THE POSTERIOR CUFF. APPROXIMATELY 1.4 CM OF THE RAIL SUTURE WAS ATTACHED TO THE POSTERIOR NEEDLE TIP. THESE FINDINGS ARE CONSISTENT WITH THE SUTURE BEING DEPLOYED AND HARVESTED FROM THE DEVICE. A REVIEW OF THE RECEIVING AND INSPECTION RECORDS FOR THE SUTURE FOUND THAT THE SUTURE PASSED INSPECTION AND WAS WITHIN SPECIFICATIONS. THE SUTURE PULLING OUT OF THE ARTERY DURING KNOT TIGHTENING CAN BE INFLUENCED BY MANY FACTORS, INCLUDING, BUT NOT LIMITED TO; MANUFACTURING, FAILURE TO POSITION AND MAINTAIN THE DEVICE AT A 45-DEGREE ANGLE THROUGHOUT DEPLOYMENT, ROTATING THE DEVICE AT ANY POINT DURING PLUNGER/NEEDLE DEPLOYMENT, DEPLOYMENT IN CHALLENGING ANATOMIES (E.G. HEAVY CALCIFIED ARTERIES, MORBIDLY OBESE PATIENTS, ETC.), AGGRESSIVELY DEPLOYING OR REMOVING THE PLUNGER AND / OR INADEQUATE POSITIONING OF THE FOOT AGAINST THE ARTERIAL WALL, EITHER OF CAN RESULT IN PARTIAL OR INCOMPLETE TISSUE CAPTURE CAUSING THE SUTURE TO BE PULLED OUT WHEN TENSION IS APPLIED. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT TO AN INSPECTION DURING MANUFACTURING. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY. BASED ON THE ANALYSIS, INSPECTION CRITERIA AND THE REPORTED INFORMATION THE REPORTED SUTURE PULLING OUT OF THE ARTERY EXPERIENCED DURING THE PROCEDURE, AND SUBSEQUENT FAILURE TO ACHIEVE HEMOSTASIS, APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT DURING USE OF THE PRODUCT. NO MANUFACTURING OR QUALITY INSPECTION DEFICIENCY WAS DETECTED WITH THE RETURNED COMPONENTS. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCOMFORMING MATERIAL RECORDS FOR THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT.

    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 OTHER PROGLIDE IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF A MODERATELY SCARRED AND CALCIFIED COMMON FEMORAL ARTERY AFTER A PERIPHERAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. REPORTEDLY, A NEEDLE-TO-CUFF MISS OCCURRED. WHEN THE NEEDLE PLUNGER WAS REMOVED, NO SUTURE WAS ATTACHED TO THE NEEDLES. THE DEVICE WAS REMOVED OVER A GUIDE WIRE AND A SECOND PROGLIDE DEVICE WAS ATTEMPTED, BUT AS THIS KNOT WAS ADVANCED TO THE ARTERY THE SUTURE PULLED OUT OF THE VESSEL. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. 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 960206H

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention