BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABIOMED 14F INTRODUCER KIT FOR IMPELLA

    MDR report key: 7902918 · Received September 24, 2018

    Report

    Report Number
    1035166-2018-00036
    Event Type
    Injury
    Date Received
    September 24, 2018
    Date of Event
    March 26, 2018
    Report Date
    September 24, 2018
    Manufacturer
    OSCOR INC
    Product Code
    DYB
    UDI-DI
    00813502010664
    PMA / PMN Number
    K122084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6: A PRELIMINARY REVIEW SHOWED THERE WERE NO MANUFACTURING REJECTS OR ANOMALIES OF THIS EVENT TYPE RECORDED IN THE DEVICE HISTORY RECORD. CONCLUSION NOT YET AVAILABLE AS THE INVESTIGATION IS ON-GOING. H11: DURING OUR FINAL INVESTIGATION, IT WAS DISCOVERED THE INITIAL MDR 1035166-2018-00036 (B)(4) REPORT HAD FAILED SUBMISSION. BASED UPON OUR FINDINGS, WE HAVE CORRECTED THE REPORTED FAILURE IN THIS INITIAL MDR REPORT. OSCOR INC., IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFORMATION OBTAINED BY OSCOR INC., WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, OSCOR, INC., OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, OSCOR, INC., OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, OSCOR, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED RETROSPECTIVELY PER FDA REQUEST DURING OUR FINAL INVESTIGATION, IT WAS DISCOVERED THE INITIAL MDR CMP (B)(4) REPORT HAD FAILED SUBMISSION. BASED UPON OUR FINDINGS, WE HAVE CORRECTED THE REPORTED FAILURE IN TMDR FOLLOW UP 2 MDR SUBMITTED ON 09/26/2018. OSCOR INC., IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFORMATION OBTAINED BY OSCOR INC., WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, OSCOR, INC., OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, OSCOR, INC., OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, OSCOR, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 0

    ON (B)(6) 2018, DURING A HRPCI PROCEDURE, THE DILATOR PERFORATED A L-ILIAC ARTERY. THE PHYSICIAN OBSERVED THE INCIDENT DURING THE ACTUAL PROCEDURE. AFTER THE PHYSICIAN HAD USED THE ABIOMED .018 WIRE AND THE BENSON WIRE, IT WAS NOTED THAT THE DILATOR PERFORATED L- ILIAC. A BALLOON USED TO CONTROL BLEEDING AND THE PERFORATION WAS REPAIRED. A 7F INTRODUCER WAS USED ABOVE PERFORATION TO DO INTERVENTION AND THE IMPELLA WAS PLACED WITHOUT ISSUE INSIDE R-ILIAC. THE PHYSICIAN USED BALLOON AND STENTS TO RCA AND KISSING BALLOONS AND STENTS TO LAD, LM AND CIRC. PRECLOSE X 2 WAS ALSO UTILIZED. PATIENT WAS REPORTED TO BE STABLE.

    Description of Event or Problem · 0

    ON (B)(6) 2018, DURING A HRPCI PROCEDURE, THE DILATOR PERFORATED A L-ILIAC ARTERY. THE PHYSICIAN OBSERVED THE INCIDENT DURING THE ACTUAL PROCEDURE. AFTER THE PHYSICIAN HAD USED THE ABIOMED .018 WIRE AND THE BENSON WIRE, IT WAS NOTED THAT THE DILATOR PERFORATED L- ILIAC. A BALLOON USED TO CONTROL BLEEDING AND THE PERFORATION WAS REPAIRED. A 7F INTRODUCER WAS USED ABOVE PERFORATION TO DO INTERVENTION AND THE IMPELLA WAS PLACED WITHOUT ISSUE INSIDE R-ILIAC. THE PHYSICIAN USED BALLOON AND STENTS TO RCA AND KISSING BALLOONS AND STENTS TO LAD, LM AND CIRC. PRECLOSE X 2 WAS ALSO UTILIZED. PATIENT WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745363 ABIOMED 14F INTRODUCER KIT FOR IMPELLA INTRODUCER, CATHETER DYB OSCOR INC 0052-3025 C1-13895 00813502010664

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention