BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10 F DIREX STEERABLE SHEATH

    MDR report key: 6408059 · Received March 15, 2017

    Report

    Report Number
    1035166-2017-00022
    Event Type
    Malfunction
    Date Received
    March 15, 2017
    Date of Event
    February 22, 2017
    Report Date
    April 20, 2017
    Manufacturer
    OSCOR INC.
    Product Code
    DYB
    UDI-DI
    08714729858966
    PMA / PMN Number
    K122960
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION NOT YET AVAILABLE-EVALUATION IN PROGRESS.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION: ONE DIREX 10F INTRODUCER SHEATH FROM LOT# C8-03237 WAS RECEIVED BACK FROM THE CUSTOMER WITH THE DILATOR. THERE WERE NO OTHER ACCESSORIES. BLOOD WAS FOUND ON AND INSIDE THE SHEATH AND DILATOR. THE HEMOSTASIS VALVE WAS TORN, OTHERWISE, THE SHEATH AND HANDLE LOOKED NORMAL. SUMMARY OF FINAL ANALYSIS: RETURNED DEVICE ANALYSIS REVEALS ONE DIREX 10F INTRODUCER SHEATH WITHIN MANUFACTURING SPECIFICATIONS. ACCORDING TO THE REPORT, THE VALVE WAS LEAKING AND ALLOWING AIR IN THE SYSTEM. UPON EVALUATION OF THE RETURNED SHEATH, IT WAS FOUND THAT THE INSERTION POINT INTO THE HEMOSTASIS VALVE WAS IDENTIFIED TO BE CONSIDERABLY OFF CENTER OF THE HELICAL CUTS, CREATING A TEAR IN THE VALVE. THE INSTRUCTIONS FOR USE SAYS: ANY DEVICE/COMPONENT INSERTED THROUGH THE HEMOSTATIC VALVE OF THE SHEATH SHOULD BE WET AND PLACED THROUGH THE CENTER OF THE VALVE TO PREVENT TEARING OF THE SEAL AND LEAKAGE. THIS VALVE LEAKED AS A RESULT OF THE OFF CENTER INSERTION DUE TO MISHANDLING OUT IN THE FIELD. THE REASON FOR RETURN WAS CONFIRMED, HOWEVER, NO MANUFACTURING DEFECTS WERE FOUND. THE SHEATHS ARE 100% INSPECTED BY QA PER PROCEDURE (DESTINO STEERABLE GUIDING SHEATH IN-PROCESS AND FINAL INSPECTION). THERE WERE NO MANUFACTURING REJECTS OR ANOMALIES OF THIS TYPE RECORDED IN THE DEVICE HISTORY RECORD. THE SHEATH PASSED ALL IN-PROCESS AND QA FINAL INSPECTION STEPS BEFORE SHIPPING TO THE CUSTOMER INCLUDING VISUAL, DIMENSIONAL AND LEAK TESTING. A REVIEW OF RISK FOR THIS FAILURE MODE IDENTIFIED THE RISK TO BE MEDIUM RISK. BASED ON THIS INFORMATION, A CAPA IS NOT REQUIRED FOR THIS EVENT. OSCOR WILL CONTINUE TO MONITOR THIS DEVICE FOR COMPLAINT TRENDS AND RISK. QUALITY ASSURANCE PROCEDURE/ DESTINO STEERABLE GUIDING SHEATH IN-PROCESS AND FINAL INSPECTION A 100% VISUAL INSPECTION IS PERFORM, THE LINER TO BE FREE OF ANY WRINKLES, SCRATCHES AND THAT IT IS TIGHTLY STRETCHED THROUGHOUT THE MANDREL. ENSURE THAT THE ENDS ARE PROPERLY TIED. WHITE DISCOLORATION OF THE LINER IS AN INDICATION THAT THE LINER IS OVERSTRETCHED. RETURN THE OVERSTRETCHED UNIT TO THE LINER STATION FOR REPLACEMENT OF LINER. INSERT THE GO-NO-GO INTO PROXIMAL END OF THE SHAFT TO ASSURE INNER LUMEN IS FREE ANY OBSTRUCTS MATERIAL. THE DILATOR SHOULD PASS SMOOTHLY WITHOUT RESISTANCE THRU THE PROXIMAL END OF THE SHAFT ALL THE WAY THRU UNTIL IT IS PROTRUDING AT DISTAL TIP. THERE SHOULD BE MINIMAL GAP BETWEEN SHAFT AND DILATOR AT DISTAL END. INSPECT HUB FOR FM, CRACKS, SINKING OR UNFILLED AREAS. HUB SHOULD BE SMOOTH. LOOK INSIDE THE HUB FOR IRREGULARITIES OR WAVINESS. VERIFY PRESENCE OF CHAMFER AND ROUNDNESS OF PARTS. LOOK INSIDE OF THE HUB FOR ANY SIGNS OF DELAMINATING OR ANY DAMAGE TO THE SHAFT RESULTING FROM THE OVER-MOLDING PROCESS. PERFORM LEAK TEST ACCORDING TO PROCEDURE. THE LEAK TEST IS PERFORMED 100% BY MANUFACTURING PERSONNEL AND IS OBSERVED BY QUALITY ASSURANCE PERSONNEL. TEST SIDEPORT FOR OCCLUSION BY ATTACHING A 10 CC SYRINGE WITH PLUNGER COMPLETELY PULLED OUT TO THE OPEN STOPCOCK VALVE. TEST BOTH OUTLETS OF THE STOPCOCK, ONE AT A TIME. WHEN TESTING ONE OUTLET, MAKE SURE THE OTHER IS IN OFF POSITION. PUSH AND PULL THE PLUNGER OF THE SYRINGE TO CONFIRM AIR FLOW THROUGH SIDEPORT AND TUBE. IF THERE IS OBSTRUCTION OR BLOCKAGE, IT WILL BE DIFFICULT TO OPERATE THE PLUNGER. NO SHAFTS SHOULD BE ACCEPTED WHERE BLOCKAGE IS FELT. THE INSTRUCTIONS FOR USE (IFU) INFORMS THE USER OF THESE PRECAUTION, NEVER ADVANCE, TORQUE, OR WITHDRAW SHEATH WHEN RESISTANCE IS MET. DETERMINE CAUSE BY FLUOROSCOPY AND THEN TAKE REMEDIAL ACTION. PLACE DILATOR INSIDE THE SHEATH AND LOCK BOTH HUBS TOGETHER. THREAD THE DILATOR/SHEATH ASSEMBLY OVER THE GUIDEWIRE, USING A SLIGHT TWISTING MOTION. NOTE: ANY DEVICE/COMPONENT INSERTED THROUGH THE HEMOSTATIC VALVE OF THE SHEATH SHOULD BE WET AND PLACED THROUGH THE CENTER OF THE VALVE TO PREVENT TEARING OF THE SEAL AND LEAKAGE. SLOWLY REMOVE THE DILATOR FROM THE SHEATH. CAUTION: RAPID REMOVAL MAY DAMAGE THE VALVE MEMBRANE RESULTING IN BLOOD FLOW THROUGH THE VALVE.

    Description of Event or Problem · 1

    PER SHORT FORM: DR HAD AN ISSUE WITH A SHEATH RECENTLY DURING A PVI IN THAT THE VALVE WAS LEAKING AND ALLOWING AIR IN THE SYSTEM'. PER SHORT FORM: PROCEDURE OUTCOME: A DIFFERENT SHEATH. DEVICE USED FOR TREATMENT OR DIAGNOSIS? NO. WHEN WAS THE PROBLEM NOTICED: DURING PROCEDURE WHERE DID PROBLEM OCCUR: INSIDE THE PATIENT. FIRST TIME UNIT WAS USED: YES. TREATMENT OR DIAGNOSIS: TREATMENT. SEE BELOW REGARDING SR RESPONSE. WHAT WAS THE PATIENT'S AGE, GENDER AND WEIGHT? (B)(6). WHERE THERE ANY PATIENT COMPLICATION'S DUE TO THE EVENT? NO COMPLICATIONS AS ISSUE WAS DETECTED, HOWEVER CHANGE OF SHEATH WAS REQUIRED. CAN YOU PLEASE CLARIFY THE STATEMENT "ALLOWING AIR IN THE SYSTEM"? THE ONE WAY VALVE WAS NOT FUNCTIONING CORRECTLY AND ALLOWING BLOOD OUT OF THE SYSTEM, AS WELL AS LETTING AIR INTO IT. WAS THE AIR IN THE SYSTEM DETRIMENTAL TO THE PATIENTS' HEALTH STATUS? IF CONTINUED USE OF THE SHEATH HAD BEEN ALLOWED THEN YES AS IT COULD OF INTRODUCED AIR EMBOLI INTO THE LEFT SIDE OF THE PATIENTS HEART RESULTING IN STROKE OR MI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189935 10 F DIREX STEERABLE SHEATH INTRODUCER, CATHETER DYB OSCOR INC. M004DS400 C8-03237 08714729858966

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR