BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDESTAR¿ STEERABLE GUIDING SHEATH

    MDR report key: 16084045 · Received January 2, 2023

    Report

    Report Number
    1035166-2023-00001
    Event Type
    Injury
    Date Received
    January 2, 2023
    Date of Event
    December 6, 2022
    Report Date
    July 6, 2023
    Manufacturer
    OSCOR INC.
    Product Code
    DYB
    UDI-DI
    00885672010911
    PMA / PMN Number
    K140406
    Adverse Event
    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

    THE FOLLOWING SECTIONS WERE UPDATED IN FOLLOW-UP 1. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE INVESTIGATION WAS FOCUSED ON A REVIEW OF PRODUCT DOCUMENTATION. THE DEVICE HISTORY RECORDS WERE REVIEWED TO CONFIRM THAT THE DEVICE PASSED ALL APPLICABLE IN-PROCESS AND FINAL INSPECTIONS. THE EXACT CAUSE OF THE PRODUCT ISSUE CANNOT BE DETERMINED, AND THE CLINICAL OBSERVATION COULD NOT BE CONFIRMED. HOWEVER, FOLLOWING CONTROLS ARE IN PLACE TO MITIGATE THE REPORTED PRODUCT ISSUE. QA FINAL INSPECTION OF THE FINISHED ADAPTOR PER PROCEDURE "BIPOLAR LEAD ADAPTORS/EXTENSIONS FINAL INSPECTION". 100% INSPECTION OF PRODUCT HAS TO BE PERFORMED UNDER 10X MICROSCOPE. SET SCREWS AND TRANSPORT PROTECTION PIN INSPECTION (VISUAL INSPECTION) SCREW SEALS (TWO KNOBS ON THE RECEPTACLE) ARE CUT APPROXIMATELY IN THE CENTER AND ARE SHAPED AS A TROKAR CUT. THEY WILL OPEN DURING THE INSERTION OF THE SCREWDRIVER AND WILL RESEAL AFTER REMOVING THE SCREWDRIVER. INSERT THE APPROPRIATE "TEST" CONNECTOR INTO THE RECEPTACLE AND TIGHTEN THE SET SCREW USING THE 14 IN/OZ. TORQUE WRENCH (EITHER (B)(6)). THE TORQUE WRENCH MUST CLICK WHICH VERIFIES THE SET SCREW WAS TIGHTENED CORRECTLY. INSTRUCTIONS FOR USE (IFU) PRECAUTIONS, DIRECTIONS FOR USE: 1. DO NOT REMOVE THE CONNECTOR OF THE LEAD TO BE ADAPTED. 2. INSERT A TORQUE WRENCH THROUGH THE SCREW SEALS OF THE BIPOLAR IS-1 RECEPTACLE AND TURN BOTH SCREWS 1/4 - 1/2 TURN (NO MORE THAN 1/2 TURN) COUNTERCLOCKWISE AND REMOVE THE WHITE SAFETY TRANSPORTATION PIN "A" 3. INSERT THE LEAD CONNECTOR COMPLETELY INTO THE RECEPTACLE PART OF THE EXTENSION. CONFIRM THAT THE CONNECTOR PIN IS VISIBLE IN HOLE "B" OF THE RECEPTACLE. 4. TIGHTEN BOTH SCREWS "C" OF THE RECEPTACLE WITH THE SCREWDRIVER. A LIGATURE MAY BE PLACED IN THE GROOVE OF THE RECEPTACLE'S END TO PREVENT BODY FLUIDS FROM INGRESSING. 5. AFTER REMOVING THE SCREWDRIVER, USE SILICONE MEDICAL ADHESIVE ON THE SCREW SEALS FOR PROTECTION AGAINST BODY FLUID INGRESSION. NO CORRECTIONS OR CORRECTIVE ACTIONS WILL BE TAKEN. DEVICE D WAS NOT RETURNED FOR ANALYSIS AND REVIEW OF THE MANUFACTURING DOCUMENTS DID NOT REVEAL ANY DISCREPANCIES THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THIS COMPLAINT IS NON-VERIFIABLE. 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

    IT WAS NOT POSSIBLE TO OPEN THE BALLOON CATHETER FULLY (INFLATION INDEX <0,7), CHANGING THE BALLOON WAS NECESSARY. AFTER CHANGING THE BALLOON PATIENT HAD ST ELEVATIONS IN THE BODY SURFACE ECG: APPARENTLY WITH THE CHANGING SOME AIR WAS INTRODUCED IN THE PATIENT. THERE WAS A 20 MINUTE DELAY IN THE PROCEDURE. AFTER THE PROCEDURE, WHEN THE PATIENT WAS NOT MORE UNDER ANESTHESIA, HE COULD NOT MOVE HIS ONE HAND/ARM AND HAD SPEECH DISORDERS. THE NEUROLOGIST ORDERED A CT SCAN OF THE HEAD. NOTHING WAS FOUND. AFTER A WHILE THE SYMPTOMS GOT BETTER. THE NEXT DAY THE PATIENT RECEIVED AN MRI OF THE HEAD AND SMALL AIR EMBOLISMS WERE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1563276 GUIDESTAR¿ STEERABLE GUIDING SHEATH INTRODUCER, CATHETER DYB OSCOR INC. D141103 00885672010911

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| L| R