BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADELANTE SAFESHEATH ULTRA LITE

    MDR report key: 18118847 · Received November 13, 2023

    Report

    Report Number
    1035166-2023-00128
    Event Type
    Malfunction
    Date Received
    November 13, 2023
    Date of Event
    October 16, 2023
    Report Date
    December 13, 2023
    Manufacturer
    OSCOR INC.
    Product Code
    DYB
    UDI-DI
    10885672000032
    PMA / PMN Number
    K073100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    ONE 15F SAFESHEATH ULTRA LITE WAS RETURNED FROM THE CUSTOMER WITH THE DILATOR. THERE WERE OTHER NON-OSCOR ACCESSORIES THAT ACCOMPANIED THE SHEATH AND DILATOR. BLOOD WAS FOUND ON ALL COMPONENTS. ACCORDING TO THE EVENT DESCRIPTION SUMMARY, AFTER INSERTING THE DILATOR INTO THE BODY THE DOCTOR REALIZED THAT THE TIP OF THE DILATOR BROKE INTO 2 PIECES OF ABOUT 1CM. THE DILATOR WAS RECEIVED BACK FROM THE CUSTOMER WITH THE TIP COMPLETELY BROKEN OFF. AN EXTRACTION DEVICE (SNARE) WAS USED TO RETRIEVE A PIECE OF THE TIP FROM THE PATIENT. THE ENTIRE TIP WAS NOT RECEIVED BACK FROM THE CUSTOMER. ONLY A PORTION OF THE TIP WAS RETURNED. RETURNED DEVICE ANALYSIS REVEALED THE TIP OF THE DILATOR BROKE OFF. IT IS UNKNOWN IF THE GUIDEWIRE USED IN THE PROCEDURE WAS COMPATIBLE WITH THE DILATOR. ALSO, THE TECHNIQUE IN WHICH THE GUIDEWIRE WAS REMOVED FROM THE DILATOR COULD HAVE BEEN A FACTOR IN THE BREAKAGE OF THE TIP. A POTENTIAL CAUSE OF THIS ISSUE COULD BE IF THE GUIDEWIRE WAS PULLED OUT OF THE DILATOR AT AN ANGLE, THERE WOULD BE A POSSIBILITY OF BREAKAGE. SINCE ONLY A PORTION OF THE DILATOR TIP WAS RETURNED, THE DEFINITE CAUSE OF TIP BREAKAGE COULD NOT BE DETERMINED. THIS INCIDENT WILL BE MONITORED FOR FUTURE OCCURRENCES. NO MANUFACTURING REJECTS OR ANOMALIES OF THIS TYPE WERE RECORDED IN THE DEVICE HISTORY RECORD. THE INTRODUCER SHEATH AND DILATOR PASSED ALL IN-PROCESS AND QA FINAL INSPECTION STEPS BEFORE SHIPPING TO THE CUSTOMER, INCLUDING VISUAL, DIMENSIONAL AND MECHANICAL TESTS. OPERATIONS PROCEDURE(S) PER QA PROCEDURE (ADELANTE-S INTRODUCER DILATOR IN PROCESS AND FINAL INSPECTION): FIRST 5 GOOD SAMPLES VERIFY THAT THE TIP IS ROUND, THAT THE SURFACE OF THE DILATOR IS SMOOTH AND VISUALLY INSPECTED BY BURRS OR SOME OTHER DAMAGE. VERIFY THAT THE PARTS ARE FREE OF GREASE OR RESIDUE CONTAMINATION. INSERTT MANDREL OR GUIDEWIRE (0.038") INTO PROXIMAL END OF DILATOR THROUGH TIP END FOR CLEARANCE VERIFICATION. CAREFULLY INSERT GUIDEWIRE (0.038") INTO PROXIMAL (HUB) END OF DILATOR ALL THE WAY THROUGH THE TIP TO VERIFY TIP CLEARANCE AND VERIFY THERE IS NO FOREIGN MATERIAL IN THE DILATOR. DO NOT FORCE THE GUIDEWIRE THROUGH THE DILATOR. IF YOU ENCOUNTER RESISTANCE, STOP, REMOVE THE GUIDEWIRE AND CONTACT A SUPERVISOR FOR FURTHER INSTRUCTIONS. PER IFU: DILATORS, CATHETERS, AND PACING LEADS SHOULD BE REMOVED SLOWLY FROM THE SHEATH. RAPID REMOVAL MAY DAMAGE THE VALVE MEMBERS RESULTING IN BLOOD FLOW THROUGH THE VALVE. NEVER ADVANCE OR WITHDRAW GUIDE WIRE OR SHEATH WHEN RESISTANCE IS MET. DETERMINE CAUSE BY FLUOROSCOPY AND TAKE REMEDIAL ACTION. CORRECTIONS ARE NOT REQUIRED BECAUSE THE INVESTIGATION DID NOT CONCLUDE THAT THE PRODUCT OR PROCESS DID NOT MEET SPECIFICATION AT THE TIME OF SHIPMENT. THE INVESTIGATION CONCLUDED THAT THE PRODUCT MET SPECIFICATION AT THE TIME OF SHIPMENT. 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

    FOR A CRYOABLATION CASE THE DOCTOR FIRST PERFORMED THE TRANSSEPTAL PUNCTURE TO GET ACCESS TO THE LEFT ATRIUM WITH A TRANSSEPTAL SHEATH AND NEEDLE. AFTER THE TRANSSEPTAL PUNCTURE THE NEEDLE WAS REMOVED AND A GUIDEWIRE WAS PLACED IN THE LEFT ATRIUM. THEN THE TRANSSEPTAL SHEATH WAS REMOVED AND THE DOCTOR INSERTED THE ADELANTE SAFESHEATH ULTRA LITE DILATOR BY FEMORAL ACCESS INTO THE BODY OF THE PATIENT TO PREDILATE. AFTER INSERTING THE DILATOR INTO THE BODY THE DOCTOR REALIZED THAT THE TIP OF THE DILATOR BROKE INTO 2 PIECES OF ABOUT 1CM. THE DOCTOR REMOVED THE DILATOR AND WAS ABLE TO REMOVE ONE OF THE BROKEN PIECES FROM THE BODY OF THE PATIENT. THE SECOND PIECE REMAINED IN THE BODY OF THE PATIENT OUTSIDE THE VEIN. NO ADVERSE PATIENT SIDE EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2079763 ADELANTE SAFESHEATH ULTRA LITE INTRODUCER, CATHETER DYB OSCOR INC. ASUP151318P C1-19790 10885672000032

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown