BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOURGUIDE¿ STEERABLE SHEATH

    MDR report key: 16488615 · Received March 6, 2023

    Report

    Report Number
    1035166-2023-00022
    Event Type
    Malfunction
    Date Received
    March 6, 2023
    Date of Event
    February 3, 2023
    Report Date
    August 7, 2023
    Manufacturer
    OSCOR.INC
    Product Code
    DYB
    UDI-DI
    00850232006031
    PMA / PMN Number
    K120459
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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

    CORRECTION TO A4: PATIENT WEIGHT NOT INCLUDED AT INITIAL SUBMISSION. CORRECTION TO 7A: ANSWER SHOULD HAVE BEEN NO. THE DEVICE WAS USED IN TREATMENT. ONE 6.5F TOURGUIDE STEERABLE GUIDING SHEATH WAS RETURNED FROM THE CUSTOMER WITHOUT THE DILATOR. THERE WERE NO OTHER ACCESSORIES. BLOOD WAS FOUND ON AND INSIDE THE SHEATH. UPON RECEIPT OF THE SHEATH, IT WAS FOUND THAT THE GREEN HUB CAP WAS DETACHED FROM THE HUB. THE PHOTOS BELOW SHOW THE CAP AND HUB UNDER MAGNIFICATION. THE CAP SNAP FEATURE WHICH IS INTENDED TO SERVE AS A MECHANICAL JOINT HOLDING THE CAP IN PLACE WAS FOUND TO BE PROPERLY FORMED. VERY SLIGHT OUT OF ROUNDNESS WAS OBSERVED, BUT WAS NOT FOUND TO HAVE ANY EFFECT ON THE SNAP FEATURE STRUCTURAL INTEGRITY. ADHESIVE IS ADDED TO FURTHER STRENGTHEN THE BOND AND ADHESIVE RESIDUE WAS OBSERVED UNDERNEATH THE HUB CAP AND ON THE HUB ITSELF. THE DEVICE HISTORY RECORDS WERE REVIEWED TO CONFIRM THAT THE DEVICE PASSED ALL APPLICABLE IN-PROCESS AND FINAL INSPECTIONS. NO SPECIFIC MANUFACTURING DEFECTS WERE IDENTIFIED ON THE DEVICE ANALYSIS, AFTER REVIEW AND INSPECTION. AS ESTABLISHED IN ET200053-R, THE MECHANICAL FASTENING JOINT OBTAINED WITH THE SNAP FEATURE BUILT INTO THE SHEATH CAP IS CAPABLE OF WITHSTANDING A LONGITUDINAL FORCE OF 15 N OR GREATER, AS REQUIRED BY ISO 11070. THE MOST PROBABLE CAUSE OF THE REPORTED DEVICE FAILURE IS THAT A FORCE EXCEEDING 15N WAS APPLIED ON THE CAP, OR A LATERAL JERKING (SHEAR) MOTION WAS APPLIED TO THE DEVICE IN WHICH CASES A SLIGHT DEFORMATION (OVALITY) ON THE THINNER WALL OF THE CAP, MAY FACILITATE DISENGAGEMENT WHEN UNDER TENSION, THROUGH INTERNAL PRESSURE BUILDUP OR DURING DEVICE REMOVAL AND / OR WITHDRAWAL. NO MANUFACTURING REJECTS OR ANOMALIES OF THIS TYPE WERE RECORDED IN THE DEVICE HISTORY RECORD. THE INTRODUCER SHEATH PASSED ALL IN-PROCESS AND QA FINAL INSPECTION STEPS BEFORE SHIPPING TO THE CUSTOMER, INCLUDING VISUAL, DIMENSIONAL AND MECHANICAL TESTS. NO MANUFACTURING DEFECTS WERE FOUND. PER PROCEDURE (NON-PEELABLE SHEATH FINAL ASSEMBLY) GLUE IS PLACED USING A GLUE DISPENSING TIP BELOW THE SEAL AROUND THE OUTER RIM OF THE SHEATH HUB. THE BONDED CAP OF APPROPRIATE COLOR IS SEATED PROPERLY OVER THE HUB AND IS SECURED WITH A SHEATH ASSEMBLY FIXTURE. THE SHEATH IS ALLOWED TO REMAIN IN THE FIXTURE FOR AT LEAST 2 MINUTES AFTER SECURING THE LAST SHEATH IN THE FIXTURE. AFTER IT IS REMOVED FROM THE FIXTURE, ENSURE THAT THERE IS NO EXCESS ADHESIVE. AFTER THE FIXTURE IS REMOVED, EACH SHEATH IS LAID FLAT ON THE TABLE FOR A MINIMUM OF 15 MINUTES BEFORE PROCEEDING. SHEATH ASSEMBLIES MUST REMAIN UNDISTURBED FOR A MINIMUM OF 15 MINUTES. BONDED CAPS ARE VISUALLY INSPECTED AFTER CURING. GAP BETWEEN THE BONDED CAP AND THE HUB SHOULD NOT EXCEED 0.020". SHEATH SHOULD BE FREE OF DAMAGES AND DEFECTS. PER PROCEDURE (DESTINO STEERABLE GUIDING SHEATH IN-PROCESS AND FINAL INSPECTION) CAP AND SEAL ARE INSPECTED AND THE RESULTS ARE REGISTERED ON THE FORM. SAMPLE SIZE: ANSI Z 1.4, GEN LEVEL I, NORMAL, AQL 1.5 NORMAL LEAK TEST IS PERFORMED ACCORDING TO PROCEDURE BASED ON AVAILABLE LEAK TESTER. THE LEAK TEST IS PERFORMED BY MANUFACTURING PERSONNEL AT 100% AND IS OBSERVED BY QUALITY ASSURANCE PERSONNEL. PER IFU: USE THE SIDEPORT, LOCATED AT THE HANDLE, TO INJECT CONTRAST SOLUTION OR FLUSH THE STEERABLE SHEATH. THE STEERABLE SHEATH MUST BE THOROUGHLY FLUSHED WITH EITHER SALINE OR HEPARINIZED SALINE AND FREE OF AIR PRIOR TO USE TO AVOID AIR EMBOLISM TO THE PATIENT. ASPIRATION AND FLUSHING OF THE SHEATH SHOULD BE PERFORMED FREQUENTLY TO HELP MINIMIZE THE POTENTIAL FOR AIR EMBOLISM. FOR INJECTING OR ASPIRATING THROUGH THE SHEATH, USE THE SIDEPORT ONLY WITH STOPCOCK. PRIOR TO INFUSION, REMOVE ALL AIR USING THE SIDEPORT. BASED ON THE INVESTIGATION, A CAPA IS NOT REQUIRED AS NO ISSUES RELATED TO DESIGN, MANUFACTURING OR LABELING OF THE PRODUCT WERE REVEALED. 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

    HEMOSTATIC VALVE FELL OUT AND BLOOD LEAKED ONTO THE TABLE. USED NEW DEVICE TO FINISH PROCEDURE AS NORMAL. THE PATIENT RECEIVED TREATMENT. NO INJURY TO PATIENT. ADDITIONAL PATIENT INFORMATION RECEIVED: PATIENT RECEIVED COELIAC ARTERY ANEURYSM STENT GRAFTING. BLOOD LOST REPORTED AS 100MLS - ISH. 5F STANDARD SHEATH INTRODUCED THROUGH THE END OF THE DEVICE (WHERE THE HEMOSTATIC VALVE WAS) TO STOP THE BLEEDING AND ALLOW A SUPPORTIVE WIRE TO BE INTRODUCED TO FACILITATE EXCHANGE. SAME TYPE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A 10 MINS DELAY FINDING A NEW SHEATH - PUT IN SUPPORTING GUIDEWIRE AND EXCHANGE. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1574128 TOURGUIDE¿ STEERABLE SHEATH INTRODUCER, CATHETER DYB OSCOR.INC TG0655509 DP-16774 00850232006031

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male