BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFESHEATH® II

    MDR report key: 17661639 · Received August 31, 2023

    Report

    Report Number
    1035166-2023-00093
    Event Type
    Malfunction
    Date Received
    August 31, 2023
    Date of Event
    August 2, 2023
    Report Date
    October 6, 2023
    Manufacturer
    OSCOR INC.
    Product Code
    DYB
    UDI-DI
    30891492002211
    PMA / PMN Number
    K122084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONCLUSION NOT YET AVAILABLE, EVALUATION IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED AS SOON AS THE INVESTIGATION IS COMPLETE. 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

    NO PRODUCT WAS PROVIDED FOR ANALYSIS AS PRODUCT IS NOT RETURNING. THERE WAS NO PATIENT HARM AND NO INTERVENTION REPORTED. THE DEVICE HISTORY RECORDS WERE REVIEWED TO CONFIRM THAT THE DEVICE PASSED ALL APPLICABLE IN-PROCESS AND FINAL INSPECTIONS. NO PRODUCT WAS RETURNED TO OSCOR INC. FOR EVALUATION; HOWEVER, A COMPLAINT NOTIFICATION WAS PROVIDED. WITHOUT THE RETURN OF THE ACTUAL DEVICE IN QUESTION FOR EVALUATION, OSCOR INC. IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS INCIDENT. AT THIS TIME, IT IS NOT POSSIBLE TO ASSIGN A DEFINITIVE ROOT CAUSE FOR THE EVENT AS REPORTED. THE COMPLAINT IS NON-VERIFIABLE AS THE PRODUCT WAS NOT RETURNED FOR EVALUATION. BASED ON THE INVESTIGATION, A CAPA IS NOT REQUIRED. IN ADDITION, THERE WAS NO NEW FAILURE MODE IDENTIFIED AND THE RISK REMAINS ACCEPTABLE. 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

    WHILE IMPLANTING A DUAL CHAMBER PACEMAKER, ONCE BOTH LEADS HAD BEEN POSITIONED, THE IMPLANTING PHYSICIAN WAS REMOVING BOTH SAFE SHEATH INTRODUCERS, BOTH THE SAME MODEL AND LOT NUMBER, BOTH THE HUB DID NOT BREAK COMPLETELY WHEN THE DOCTOR BROKE THE HUB AND TORE THE INTRODUCER SHEATH TO REMOVE IT. THE CIRCULAR COMPONENT, THAT IS UNDER THE HEMOSTATIC VALVE, WHICH THE LEAD GOES THROUGH WAS STILL INTACT, REQUIRING THE DOCTOR TO UTILIZE OTHER METHODS TO REMOVE THAT COMPONENT OF THE SAFE SHEATH. THIS HAPPENED WITH BOTH SAFE SHEATH INTRODUCERS (6FR). THIS IS NOT THE FIRST TIME THIS HAS HAPPENED WITH THIS DOCTOR WITH THE SAFE SHEATH INTRODUCERS, 6FR. HE SAID THIS WOULD HAVE HAPPENED AT LEAST 4 TIMES IN THE LAST WEEK. ADDITIONAL INFORMATION RECEIVED 08/25/2023: THERE WERE 2 INTRODUCERS - 6FR SAFE SHEATH INTRODUCERS USED IN THIS IMPLANT BECAUSE 2 PACING LEADS WERE BEING IMPLANTED IN THE PATIENT'S HEART. THE PHYSICIAN MADE A PASSING COMMENT THAT HE HAD OBSERVED THAT THE INTRODUCER HUB DID NOT BREAK / TEAR APART AS HE HAS PREVIOUSLY EXPERIENCED MANY MANY TIMES OVER WHEN HE IMPLANTS PACING LEADS AND CRM DEVICES. ANOTHER OF MY COLLEAGUES DID REPORT THIS SAME EXPERIENCE WITH THE SAME PHYSICIAN AND SAME SAFE SHEATH 6FR INTRODUCERS, WHICH WE DISCOVERED HAD THE SAME BATCH / LOT NUMBER. PATIENT OUTCOME: A SUCCESSFUL IMPLANT - DUAL CHAMBER PACEMAKER IMPLANT ONLY ONE PACING LEAD WAS INSERTED THROUGH EACH SHEATH I.E., 2 SHEATHS USED, AND 2 PACING LEADS USED. THE CUSTOMER STATED THERE WAS NO PROCEDURE DELAY. THERE WAS NO ADDITIONAL INTERVENTION APART FROM THE IMPLANTING PHYSICIAN UTILIZING ANOTHER SURGICAL TOOL TO COMPLETE THE BREAKING OF THE SAFE SHEATH INTRODUCER HUB (THE "RUBBER RING" BELOW THE HEMOSTATIC VALVE). RELATED CASES INCLUDE: (B)(4). & (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1182412 SAFESHEATH® II INTRODUCER, CATHETER DYB OSCOR INC. SS6 DP18303 30891492002211

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female