BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIODYNAMICS SAFESHEATH ULTRA LITE

    MDR report key: 11924302 · Received June 2, 2021

    Report

    Report Number
    1035166-2021-00054
    Event Type
    Malfunction
    Date Received
    June 2, 2021
    Date of Event
    April 27, 2021
    Report Date
    September 30, 2021
    Manufacturer
    OSCOR INC.
    Product Code
    DYB
    UDI-DI
    25051684026267
    PMA / PMN Number
    K073100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTIONS WERE UPDATED IN FOLLOW-UP 2. B4, D1, D4, G3, G6, H2, H10, H11 CORRECTION: D1: CORRECTED BRAND NAME TO ANGIODYNAMICS SAFESHEATH ULTRA LITE CORRECTION: D4: CORRECTED MODEL & CATALOG NUMBER FROM V17 TO VI7 (SHOULD BE ROMAN NUMERAL'S) 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 DEVICE WAS USED FOR TREATMENT. THE DEVICE WAS NOT RETURNED FOR ANALYSIS, THEREFORE, THE CLINICAL OBSERVATION COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORDS WERE REVIEWED TO CONFIRM THAT THE DEVICE PASSED ALL APPLICABLE IN-PROCESS AND FINAL INSPECTIONS. PER PROCEDURE (ADELANTE-S INTRODUCER SHEATH IN PROCESS AND FINAL INSPECTION) OVERMOLDED SHEATH: VISUAL INSPECTION: VERIFY HUB TO BE SMOOTH, NO CRACKS, SINKING OR UNFILLED AREAS, AND CHECK FOR FM VERIFY HUB SHAPE AS PER DRAWING. CHECK FOR EXCESSIVE FLASH (MAXIMUM ALLOWABLE LIMIT IS 0.75 MM2). USING 10X MICROSCOPE, LOOK DOWN INTO HUB FOR IRREGULARITIES. VERIFY SMOOTH TRANSITION BETWEEN SHEATH AND HUB ON INSIDE OF HUB. VERIFY ONE OF THE SCORE LINES OF THE SHEATH IS ALIGNED WITH THE BREAK LINE OF THE HUB (HANDLE). BREAK AND PEEL TEST: MANUALLY BREAK THE SHEATH AND HUB AND VERIFY THAT THE SEAL SPLITS EASILY WITHOUT EXTREME ELONGATION. ALSO VERIFY THAT THE SPLIT CAP AND SEAL REMAIN SECURE AND DO NOT BREAK FREE OR LOOSEN FROM THE SHEATH HUB. STRENGTH TEST: USING SAMPLES FROM BREAK AND PEEL TEST, USE FORCE GAUGE TO DETERMINE THE STRENGTH OF THE INTRODUCER SHEATH HUB AND SIDE TUBE JOINT BY PLACING THE BROKEN AND PEELED SHEATH HUB AND SIDE TUBE IN OPPOSING PULL TESTER CLAMPS. PULL AT A RATE OF 20 IN/MIN UNTIL JOINT COMPLETELY SEPARATES. THE PEAK FORCE AT SEPARATION SHALL BE > 3.37 LBF (15N). PER IFU, ANGIODYNAMICS SSU LITE: WITHDRAW SHEATH FROM THE VESSEL. THEN REMOVE THE SHEATH BY SHARPLY SNAPPING THE TABS OF VALVE HOUSING IN A PLANE PERPENDICULAR TO THE LONG AXIS OF THE SHEATH TO SPLIT THE VALVE AND PEEL SHEATH APART WHILE WITHDRAWING FROM THE VESSEL. NO FURTHER FOLLOW-UP IS REQUIRED. BASED ON THE INVESTIGATION, A CAPA IS NOT REQUIRED AS FINDINGS DID NOT IDENTIFY A DESIGN, LABELING OR MANUFACTURING NON-CONFORMITY. 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE SHEATH BROKE INTO PIECES WHEN THE CATHETER WAS ADVANCED THROUGH THE SHEATH. THE WING OF THE SHEATH REMAINED INTACT AND THE ORANGE AND CLEAR PART OF THE INTRODUCER BROKE INTO 2 TO 4 PIECES. THIS REQUIRED THE PHYSICIAN TO CAREFULLY REMOVE ALL THE PIECES TO ENSURE NONE ARE LEFT INSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE MEDICAL INTERVENTION. PROCEDURE WAS COMPLETED WITH ANOTHER INTRODUCER. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822317 ANGIODYNAMICS SAFESHEATH ULTRA LITE INTRODUCER, CATHETER, PRODUCT CODE: DYB DYB OSCOR INC. VI7 DP-12450 25051684026267

    Patients

    Seq Age Sex Outcome Treatment
    1