BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2040420 · Received April 5, 2011

    Report

    Report Number
    2024168-2011-02394
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 11, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND IT WAS FULLY DEPLOYED MISSING ITS PLUNGER/NEEDLES ASSEMBLY, ANTERIOR CUFF AND LINK. THE SUTURE WAS FULLY FREE OF THE DEVICE WITH THE POSTERIOR NEEDLE TIP ATTACHED AND ENGAGED WITH THE POSTERIOR CUFF. THERE WAS NO DETECTED HANDLE, GUIDE OR FOOT DAMAGE. A PROXY PLUNGER WAS INSERTED INTO THE DEVICE TO CHECK FOR THE PROPER NEEDLE TRAJECTORY. THE ATTEMPT WAS SUCCESSFUL WITH BOTH NEEDLES ENTERING THEIR RESPECTIVE FOOT POCKET INDICATING PROPER NEEDLE TRAJECTORY. INSPECTION OF THE SUTURE DID NOT DETECT ANY DAMAGE AND THE PREFORMED KNOT HAD BEEN UNRAVELED. THE LINK HAD BROKEN FROM THE POSTERIOR CUFF LEAVING A SMALL AMOUNT OF LINK MATERIAL EXITING THE POSTERIOR CUFF FROM THE SWAG END OF THE CUFF. THIS CONFIRMED THE REPORTED LACK OF SUTURE DELIVERY. A LINK-TO-CUFF DETACHMENT SUGGESTED, BUT DID NOT CONFIRM, THAT THERE WAS RESISTANCE TO SUTURE MOVEMENT ENCOUNTERED WHILE RETRACTING THE NEEDLE PLUNGER, POSSIBLY DUE TO THE REPORTED MODERATELY CALCIFIED ARTERY. THERE WERE NO DETECTED DEVICE OBSERVATIONS THAT MAY HAVE CONTRIBUTED TO THE LINK TO CUFF DETACHMENT. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. BASED ON THE RESULTS OF THE INSPECTION CRITERIA AND THE ANALYSIS OF THE RETURNED COMPONENTS, THE REPORTED FAILURE TO DEPLOY THE SUTURE WAS CONFIRMED BUT NO ROOT CAUSE FOR THE LINK TO POSTERIOR CUFF DETACHMENT COULD BE DETERMINED. NO MANUFACTURING OR PRODUCT QUALITY DEFICIENCY WAS DETECTED THAT WOULD HAVE CONTRIBUTED TO THE REPORTED FAILURE TO DEPLOY THE SUTURE.

    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 DEVICE IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER.

    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 MODERATELY CALCIFIED COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, THE SUTURE DID NOT DEPLOY. A SECOND PROGLIDE WAS USED WITH THE SAME RESULTS. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. 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 950386H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention