BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 5918182 · Received August 31, 2016

    Report

    Report Number
    2024168-2016-05838
    Event Type
    Injury
    Date Received
    August 31, 2016
    Date of Event
    April 26, 2016
    Report Date
    September 21, 2016
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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 REPORTED TO BE RETAINED BY THE HOSPITAL. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE DEVICE OPERATES DIFFERENTLY THEN EXPECTED AND PERFORATION. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER SIMILAR INCIDENTS FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Description of Event or Problem · 1

    USER FACILITY MEDWATCH REPORT WAS RECEIVED STATING: A PERFORATION OCCURRED DURING PERCLOSE DEPLOYMENT. A COVERED STENT WAS INSERTED AND DEPLOYED, AND THE PERFORATION WAS REPAIRED. THERE WAS A CHANGE IN RT DP AND PT PULSES AND LT PT PULSE. WE ATTEMPTED TO PLACE AN IMPELLA DEVICE AND WENT FROM 7FR SHEATH TO 14 FR SHEATH, BUT AN ANGIOGRAM SHOWED THE SHEATH TO BE OCCLUDED AT THE DISTAL END. THE SHEATH WAS PULLED AND ATTEMPTED PLACEMENT OF PERCLOSE HOWEVER, IT APPEARED THE FOOT PLATE CAME THROUGH THE ARTERIECTOMY AND MAY HAVE RUPTURED THE VESSEL. ULTIMATELY A VIABAHN COVERED STENT WAS PLACED ACROSS THE PERFORATION SUCCESSFULLY. PERCLOSE LOT NUMBER 6012041. NO OTHER IDENTIFYING INFORMATION IS AVAILABLE REGARDING THIS DEVICE. SUBSEQUENT TO THE USER FACILITY MEDWATCH THE FOLLOWING INFORMATION HAS BEEN RECEIVED. THE PROGLIDE DEVICE WAS USED IN THE RIGHT COMMON FEMORAL ARTERY. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE. PATIENT HAD A PREVIOUS CATH PROCEDURE 1 HOUR PRIOR, SHEATH WAS STILL IN THE RIGHT GROIN WHEN PATIENT ARRIVED BACK TO THE LAB. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570661 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 6012041

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention