BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3873043 · Received June 13, 2014

    Report

    Report Number
    2024168-2014-03828
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 21, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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). CORRECTION - DEVICE STATUS CHANGED FROM RETURNING TO NOT RETURNING. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. A QUERY OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER AN INTERVENTIONAL PROCEDURE, ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PERCLOSE PROGLIDE DEVICE. REPORTEDLY, WHEN THE NEEDLE PLUNGER WAS REMOVED THE BLUE SUTURE RAIL DID NOT APPEAR. MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. POST-PROCEDURE THE PATIENT REPORTEDLY DEVELOPED A FOOT ACHE. THREE DAYS LATER COMPUTER TOMOGRAPHY SCAN REVEALED A DISSECTION AND RUPTURE IN THE FEMORAL ARTERY. NO TREATMENT WAS REPORTED. THE PATIENT IS SCHEDULED TO FOLLOW UP WITH THE VASCULAR SURGEON IN THREE MONTHS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. THE PHYSICIAN WAS REPORTED TO BE TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, IT WAS REPORTED THAT PLACEMENT OF THE PROGLIDE DEVICE SUTURE WAS ATTEMPTED IN A COMMON FEMORAL ARTERY USING THE PRECLOSE TECHNIQUE PRIOR TO A AORTIC VALVULOPLASTY PROCEDURE. THE PROCEDURAL SHEATH SIZE USED WAS AN 18F. REPORTEDLY, THE PATIENT'S VESSEL WAS FRIABLE OR EASY TO DAMAGE. THE DELAY IN THE PROCEDURE WAS DUE TO THE OBSERVED DISSECTION AND RUPTURE IN THE FEMORAL ARTERY RESULTING IN PROLONGING THE PATIENT'S HOSPITAL STAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350094 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 40203K1

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SHEATH: 18F, PLAVIX, ASPIRIN