BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM

    MDR report key: 11769630 · Received May 4, 2021

    Report

    Report Number
    9610612-2021-00359
    Event Type
    Injury
    Date Received
    May 4, 2021
    Report Date
    October 21, 2021
    Manufacturer
    AESCULAP AG
    Product Code
    FZP
    UDI-DI
    04046955241026
    PMA / PMN Number
    K202124
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED H6: CODES: INVESTIGATION RESULTS: AS OF THE DATE OF THIS REPORT THE COMPLAINT PRODUCT WAS NOT PROVIDED FOR INVESTIGATION. THEREFORE, A THOROUGH INVESTIGATION IS NOT POSSIBLE. BATCH HISTORY REVIEW: DUE TO THE FACT THAT NO LOT NUMBER WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE COMPLAINED DEVICE IS NOT POSSIBLE. THE REVIEW OF RISK ASSESSMENT REVEALED THAT THE OVERALL RISK LEVEL (SEVERITY 4(5) X PROBABILITY OF OCCURRENCE 2(5)) ACCORDING TO DIN EN ISO 14971 IS STILL ACCEPTABLE. CONCLUSION AND MEASURES / PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS A CLEAR ROOT CAUSE CONCLUSION CANNOT BE DRAWN. THERE IS NO INDICATION FOR A MATERIAL-, MANUFACTURING- OR DESIGN-RELATED FAILURE. IN THE EVENT THAT THE COMPLAINT PRODUCT WILL BE PROVIDED FOR INVESTIGATION IN THE FUTURE, AN UPDATE OF THIS REPORT WILL BE PROVIDED UNSOLICITED. BASED UPON THE INVESTIGATIONS RESULTS A PRODUCT SAFETY CASE(PSC-2020-033) WAS INITIATED. ANY ACTION REGARDING CAPA WILL BE ADDRESSED WITH THIS CASE. A PRODUCT RECALL (FSCA-255) WAS INITIATED. PRODUCT NOT SOLD NOR MARKETED ANY LONGER.

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FC700SU - PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE VEIN GRAFT CAME OFF FROM ANASTOMOSIS. IT WAS REPORTED THAT PASSPORT SYSTEM WAS USED FOR OPCAB. AFTER THE ANASTOMOSIS OF THE VEIN GRAFT TO THE AORTA WAS PERFORMED (KNOB ROTATION), THE VEIN GRAFT (SVG) CAME OFF FROM THE ANASTOMOTIC SITE AND CAUSED BLEEDING. THE BLEEDING OF HOLE BY PPS CUTTER WAS STOPPED WITH A FINGER, THEN SVG WAS ANASTOMOSED BY HAND SEWING USING A SIDE CLAMP TO COMPLETE THE PROCEDURE. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666933 PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM ANASTOMOSIS DEVICES FZP AESCULAP AG FC700SU 04046955241026

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention