BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 7022566 · Received November 10, 2017

    Report

    Report Number
    2024168-2017-08885
    Event Type
    Injury
    Date Received
    November 10, 2017
    Date of Event
    August 29, 2017
    Report Date
    November 10, 2017
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    UDI-DI
    08717648013089
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 WAS NOT RETURNED FOR ANALYSIS. THE INVESTIGATION DETERMINED THE REPORTED PATIENT EFFECTS AND TREATMENT APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING.

    Description of Event or Problem · 1

    SUS VOLUNTARY EVENT REPORT MW 5072868 WAS RECEIVED. EVENT DESCRIPTION: "ON (B)(6) 2017, A (B)(6) MALE PT WAS ADMITTED TO THE HOSPITAL WITH GUNSHOT WOUNDS. THE PT WAS TAKEN TO THE OPERATING ROOM FOR MULTIPLE SURGERIES, INCLUDING SURGERY TO ATTEND TO THE FEMORAL FRACTURE AND REPAIR FROM THE GUNSHOT THAT HAD PIERCED THROUGH THE URETHRA. WHILE IN THE OPERATING ROOM, AN IMPELLA CP WAS PLACED WITHOUT ISSUE IN THE PT. THE IMPELLA CP WAS REPORTED TO HAVE SUCCESSFULLY SUPPORTED THE PT FOR 80.67 HOURS. THE PT WAS SUCCESSFULLY WEANED FROM THE IMPELLA AND ON (B)(6) 2017 IT WAS REMOVED WITHOUT INCIDENT OR COMPLICATION. ON THE FOLLOWING DAY, (B)(6) 2017, THE PT WAS AGAIN BROUGHT INTO THE OPERATING ROOM FOR ABDOMINAL SURGERY FOR THE GUNSHOT WOUND. THE CLINICIANS ALSO NOTED THAT THE PT HAS ALSO BEEN SHOT IN THAT LEG AND THE BULLET HAD EXITED HIS HIP AND WENT INTO THE ABDOMEN NECESSITATING A FASCIOTOMY AND SURGICAL PROCEDURE THAT WAS ALSO PERFORMED ON THAT LEG. THE NEXT DAY, (B)(6) 2017, THE PT'S FOOT TURNED COLD AND ON THE FOLLOWING DAY THE PT WAS AGAIN TAKEN TO THE OPERATING ROOM FOR AN EMBOLECTOMY IN THE SUPERFICIAL FEMORAL ARTERY FOR "REMOVAL OF A FOREIGN OBJECT." THIS WAS REPORTED TO BE DUE TO THE PERCLOSE [INVALID] WHICH HAD BEEN TIED TO DURING THE IMPELLA PUMP EXPLANT. ON (8)(6) 2017, THE PT'S FOOT HAD BECOME NECROTIC, AND THE FOOT WAS AMPUTATED THE FOLLOWING DAY ON (B)(6) 2017. IT WAS REPORTED THAT THE HOSPITAL IS ATTRIBUTING THIS EVENT TO PHYSICIAN ERROR." NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798244 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 08717648013089

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S