BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 9458783 · Received December 12, 2019

    Report

    Report Number
    2024168-2019-14437
    Event Type
    Injury
    Date Received
    December 12, 2019
    Date of Event
    November 8, 2019
    Report Date
    January 30, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT RETURNING AND INVESTIGATION IS NOT COMPLETE. A FOLLOW-UP REPORT WILL BE FILED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    D4, H4: IT COULD NOT BE CONFIRMED WHICH PROGLIDE DEVICE LOT NUMBER EXPERIENCED THE REPORTED PATIENT EFFECTS; THEREFORE, THE LOT HISTORY RECORD REVIEWS ARE PROVIDED FOR BOTH LOT NUMBERS (9091041 AND 9070841). PART / LOT / SERIAL NUMBER: 12673-05 / 9091041 / NOT APPLICABLE, MANUFACTURING DATE: 10-SEPTEMBER-2019, EXPIRATION DATE: 31-JULY-2021, UNIQUE DEVICE IDENTIFIER: (B)(4). PART / LOT / SERIAL NUMBER: 12673-05 / 9070841 / NOT APPLICABLE, MANUFACTURING DATE: 08-JULY-2019, EXPIRATION DATE: 31-MAY-2021, UNIQUE DEVICE IDENTIFIER: (B)(4). THE INCIDENT INFORMATION WAS REVIEWED; HOWEVER, THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. A REVIEW OF THE LOT HISTORY RECORDS IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOTS THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE REPORTED PATIENT EFFECTS OF INFECTION AND SURGICAL PROCEDURE ARE LISTED IN THE PERCLOSE PROGLIDE INSTRUCTIONS FOR USE AS A KNOWN ADVERSE EVENT ASSOCIATED WITH USE OF SUTURE MEDIATED CLOSURE DEVICES. BASED ON THE CASE INFORMATION AND RELATED RECORD REVIEW, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED AND THE TREATMENT APPEARS TO BE RELATED TO THE CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURE OR LABELING OF THE DEVICE.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIALLY FILED REPORT, ADDITIONAL INFORMATION PROVIDED: REPORTEDLY, THERE WAS NO ISSUE DURING THE ENDOVASCULAR TREATMENT INDEX PROCEDURE ((B)(6) 2019) AND NO CLINICALLY SIGNIFICANT DELAY. THE OPERATOR DID NOT RE-PREPARE THE ACCESS SITE OR RE-GLOVE PRIOR TO PROGLIDE USE. PATIENT WAS READMITTED DUE TO INFECTION ON (B)(6) 2019 REQUIRING SURGERIES. THE PATIENT EXPERIENCED A CEREBRAL INFARCTION ON (B)(6) 2019 AND DEVELOPED PNEUMONIA. PATIENT EXPIRED ON (B)(6) 2019 DUE TO ACUTE RESPIRATORY DISTRESS SYNDROME AND SEPSIS. IN THE PHYSICIAN'S OPINION, THE DEATH IS UNRELATED TO THE PROGLIDE DEVICE AND THE GROIN INFECTION DID NOT CONTRIBUTE TO DEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT ESTIMATED. EXEMPTION NUMBER E2019001. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PUNCTURE CLOSURE OF AN UNSPECIFIED VESSEL WAS ACHIEVED USING A PROGLIDE DEVICE AFTER AN ENDOVASCULAR INTERVENTION. REPORTEDLY, A WEEK AFTER THE PROCEDURE, THE PATIENT RETURNED WITH AN INFECTION AT THE ACCESS SITE. THE PATIENT WAS TREATED WITH SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1251533 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R