BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARRIVE¿ BRAIDED TRANSSEPTAL SHEATH

    MDR report key: 8880253 · Received August 9, 2019

    Report

    Report Number
    1035166-2019-00068
    Event Type
    Injury
    Date Received
    August 9, 2019
    Date of Event
    July 5, 2019
    Report Date
    September 26, 2019
    Manufacturer
    OSCOR INC
    Product Code
    DYB
    PMA / PMN Number
    K101497
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE USED IN TREATMENT. THE DEVICE WILL NOT RETURNED FOR EVALUATION. THE LOT NUMBER OF THIS DEVICE WAS NOT PROVIDED, THEREFORE NEITHER A REVIEW OF THE DEVICE HISTORY RECORD NOR COMPLAINT HISTORY COULD BE PERFORMED. INSPECTION PROCEDURES REQUIRE ANY OSCOR PRODUCT PASS ALL IN-PROCESS AND QA FINAL INSPECTIONS BEFORE SHIPPING TO THE CUSTOMER. THERE WAS NO PERFORMANCE RELATED FAILURE REPORTED BY THE USER. NO FURTHER INVESTIGATION IS REQUIRED. BASED ON THE INVESTIGATION, A CAPA IS NOT REQUIRED AS FINDINGS DID NOT IDENTIFY A DESIGN, LABELING OR MANUFACTURING NON-CONFORMITY. THE EVENT WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. OSCOR WILL CONTINUE TO MONITOR THIS EVENT TYPE AND RISK. 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

    AS PER ADDITIONAL INFORMATION, PATIENT WAS PRESENTED TO PHYSICIAN IN GOOD CONDITION. AS PER PHYSICIAN, PATIENT MIGHT HAD CORONAROPATHY "BY STANDER". THE DEATH WAS CAUSED BY ELECTROMECHANICAL DISSOCIATION.

    Additional Manufacturer Narrative · 1

    OUR INVESTIGATION IS STILL IN PROGRESS ,FOLLOW UP REPORT WILL BE SUBMITTED IF WE FIND ANY FURTHER ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING CRYO ABLATION PROCEDURE, PHYSICIAN SUCCESSFULLY PERFORMED THE ABLATION OF THE FOUR PULMONARY VEINS. AT THE END OF THE PROCEDURE WHEN HE WAS CHECKING THE RESULTS OF THE PROCEDURE, HE FIND OUT THAT PATIENT HAD BRADYCARDIA. PATIENT HAS BEEN PACED AND HAD CARDIAC MASSAGE, PERICAR DIOCENTESIS AND PHARMACOLOGICAL TREATMENTS FOR 2 HOURS BUT HE DIED. PATIENT DIED ON (B)(6) ,2019. HOWEVER, NO ALLEGED PRODUCT ISSUE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673531 ARRIVE¿ BRAIDED TRANSSEPTAL SHEATH INTRODUCER, CATHETER DYB OSCOR INC

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention