BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TB 5F TEMPORARY BIPOLAR PACING LEAD

    MDR report key: 7843265 · Received September 4, 2018

    Report

    Report Number
    1035166-2018-00081
    Event Type
    Malfunction
    Date Received
    September 4, 2018
    Date of Event
    August 9, 2018
    Report Date
    October 29, 2018
    Manufacturer
    OSCOR INC.
    Product Code
    LDF
    UDI-DI
    00083655900991
    Removal / Correction Number
    1035166-09/07/2018-01-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS WERE REVIEWED TO CONFIRM THAT THE DEVICE PASSED ALL APPLICABLE IN-PROCESS AND FINAL INSPECTIONS. ONE 5F UNSHROUDED TEMPORARY BIPOLAR PACING LEAD WAS RECEIVED BACK FROM THE CUSTOMER. THERE WERE NO OTHER ACCESSORIES. NO VISIBLE BLOOD WAS FOUND ANYWHERE ON THE LEAD. UPON INITIAL EVALUATION OF THE RETURNED LEAD, IT WAS OBSERVED THAT THE BLACK CONNECTOR WAS BROKEN OFF COMPLETELY WITH ONLY A SMALL PIECE OF SHRINK TUBING HOLDING THE CONNECTOR TO THE WIRE. THE RED CONNECTOR WAS COMPLETELY INTACT. WHEN MEASURED WITH A MULTIMETER, IT WAS FOUND THAT THE POSITIVE BIPOLAR RESISTANCE (RED PIN TO HULL) WAS WITHIN MANUFACTURING SPECIFICATION BUT THE NEGATIVE BIPOLAR RESISTANCE (BLACK PIN TO TIP) DID NOT REGISTER AN ELECTRICAL VALUE. THE RED PIN TO HULL MEASURED 13.3 OHMS, WHICH MET THE REQUIREMENT OF 10-20 OHMS, AS SET IN FINAL INSPECTION PROCEDURES. THE BLACK PIN TO TIP DID NOT REGISTER A CURRENT WHEN MEASURED (THE SPECIFICATION INDICATES THIS SHOULD MEASURE 10-20 OHMS. RETURNED DEVICE ANALYSIS REVEALS ONE TB LEAD, 5F UN-SHROUDED, WITH AN APPROPRIATELY FUNCTIONING NEGATIVE BIPOLAR RESISTANCE AND A POSITIVE BIPOLAR RESISTANCE THAT DID NOT REGISTER A CURRENT WHEN TESTED WITH A MULTIMETER. THE BLACK CONNECTOR PIN WAS NO LONGER ATTACHED TO THE WIRE WHICH RESULTED IN NO ELECTRICAL FUNCTIONALITY. CAPA WAS PREVIOUSLY OPENED TO INVESTIGATE THE ROOT CAUSE AND TO IMPLEMENT CORRECTIVE ACTION TO PREVENT RECURRENCE OF THIS ISSUE. THE EVENT WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. OSCOR WILL CONTINUE TO MONITOR THIS EVENT TYPE AND RISK. FIELD ACTION HAS BEEN INITIATED FOR TB LEAD. THE TB LEADS ARE INSPECTED VISUALLY AND TESTED FOR ELECTRICAL CONTINUITY 100% BY QA PRIOR TO SHIPPING TO THE CUSTOMER PER PROCEDURE TEMPORARY LEAD FINAL INSPECTION (MODEL TB). THE INSTRUCTIONS FOR USE (IFU) IS PROVIDED WITH THIS DEVICE. PER THE IFU, THE PRECAUTIONS STATE, AVOID KINKING OR BENDING THE LEAD TO MINIMIZE THE RISK OF DAMAGE TO INTERNAL WIRES. 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 · 1

    CONCLUSION NOT YET AVAILABLE AS THE INVESTIGATION IS ON-GOING. A FOLLOW-UP WILL BE SUBMITTED AS SOON AS THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOR THE STIMULATION OF A PATIENT THE HOSPITAL CONNECTED THE TB TEMPORARY PACEMAKER LEAD TO AN EXTERNAL PACEMAKER, BUT WAS NOT ABLE TO STIMULATE THE PATIENT. AFTER CHECKING THE CABLE THEY RECOGNIZED THAT THE CABLE WAS BROKEN NEAR TO THE END OF THE BLACK CONNECTOR. THEY REPLACED THE TEMPORARY PACING LEAD WITH A NEW ONE AND COULD FINISH THE PROCEDURE WITHOUT ANY PROBLEMS. THE PATIENT IS STABLE AND NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685340 TB 5F TEMPORARY BIPOLAR PACING LEAD ELECTRODE, PACEMAKER, TEMPORARY LDF OSCOR INC. 020023 DP-05418 00083655900991

    Patients

    Seq Age Sex Outcome Treatment
    1