BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENDRA INTRODUCER SHEAT SET

    MDR report key: 3002547 · Received March 13, 2013

    Report

    Report Number
    2015691-2013-19530
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 15, 2013
    Report Date
    April 10, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO EDWARDS AND IS PENDING EVALUATION.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED TO EDWARDS FOR EVALUATION. VISUAL INSPECTION AND DIMENSIONAL/FUNCTIONAL EVALUATIONS WERE PERFORMED. NO LEAKS WERE OBSERVED DURING FLUSHING WITH OR WITHOUT A GUIDEWIRE. ADDITIONALLY, NO LEAKS WERE OBSERVED WHEN THE SHEATH WAS FLUSHED WITH A DELIVERY SYSTEM AND LOADER INSERTED INTO THE SHEATH. THE SHEATH WAS THEN FLUSHED AND PRESSURIZED AND NO LEAKS WERE OBSERVED WITH OR WITHOUT A DELIVERY SYSTEM AND LOADER INSERTED INTO THE SHEATH. THE LOADER WAS THEN REMOVED FROM THE SHEATH AND THE DELIVERY SYSTEM WAS LEFT INSIDE THE SHEATH. NO LEAKS OR PRESSURE DROP WAS OBSERVED IN THIS CONFIGURATION AS WELL. ALL TESTING ON THE COMPLAINT DEVICE DID NOT REVEAL ANY INDICATION OF A MANUFACTURING NON-CONFORMANCE OR ANY CONFIRMATION OF THE COMPLAINT EVENT. THERE WERE NO LEAKS OBSERVED WHILE FLUSHING AND PRESSURIZING THE SHEATH UNDER MULTIPLE CONFIGURATIONS. DUE TO THE CONDITION OF THE RETURNED DEVICE (PRESENCE OF DRIED BLOOD TRAPPED WITHIN THE SEALS OF THE SHEATH), A HEMOSTASIS LEAK TEST COULD NOT BE PERFORMED ON THE DEVICE TO CONFIRM IF THE LEAK RATE MEETS SPECIFICATION UNDER CONDITIONS REPRESENTATIVE OF THE PATIENT. AN ADDITIONAL ATTEMPT TO REMOVE THE BLOOD WAS MADE BY IMMERSING THE SHEATH IN A 3% HYDROGEN PEROXIDE SOLUTION; HOWEVER, AFTER 24 HOURS OF EXPOSURE TO THE HYDROGEN PEROXIDE, BLOOD REMAINED TRAPPED IN THE HANDLE. THE MANUFACTURING PROCESS OF 9100IS SHEATHS HAS THE FOLLOWING INSPECTIONS TO MITIGATE AGAINST SHEATH LEAKAGE: 100% VISUAL INSPECTION UNDER MAGNIFICATION FOR DAMAGE, 100% INSPECTION THAT VALVES ARE PLACED PROPERLY, AND 100% VISUAL INSPECTION FOR SHEATH SUB-ASSEMBLY. SEAL COMPONENTS ARE ALSO SAMPLED FOR INSPECTION TO BE FREE OF VOIDS, CRACKS AND MISFILLS. THESE INSPECTIONS MAKE IT HIGHLY UNLIKELY THAT A MANUFACTURING NON-CONFORMANCE COULD HAVE CAUSED A LEAK. IT SHOULD BE NOTED THAT THE PROCEDURE WAS STILL ABLE TO BE COMPLETED AND DID NOT RESULT IN ANY ADDITIONAL INTERVENTION. DUE TO THE LACK OF INFORMATION, THE ROOT CAUSE COULD NOT BE DETERMINED FOR THE REPORTED COMPLAINT. SINCE THE COMPLAINT COULD NOT BE CONFIRMED AND THERE WAS NO INDICATION OF A MANUFACTURING NON-CONFORMANCE, A CORRECTIVE ACTION IS NOT REQUIRED. DUE TO THE CONDITION OF THE RETURNED DEVICE, THE COMPLAINT COULD NOT BE CONFIRMED. ALL TESTING PERFORMED DID NOT REVEAL ANY INDICATION OF A MANUFACTURING NON-CONFORMANCE. REVIEW OF COMPLAINT HISTORY DID NOT REVEAL THAT THE OCCURRENCE RATE EXCEEDS THE FEBRUARY 2013 CONTROL LIMITS FOR THIS FAILURE MODE. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    AS REPORTED PER THE EDWARDS FIELD CLINICAL SPECIALIST (FCS), DURING A TRANSAPICAL TAVR PROCEDURE THE PHYSICIAN REPORTED THAT THERE WAS SOMETHING WRONG WITH THE HUB OF THE SHEATH AS IT WAS LEAKING ALL OVER THE PLACE.

    Description of Event or Problem · 1

    AS REPORTED PER THE EDWARDS FIELD CLINICAL SPECIALIST (FCS), DURING A TRANSAPICAL TAVR PROCEDURE THE PHYSICIAN REPORTED THAT THERE WAS SOMETHING WRONG WITH THE HUB OF THE SHEATH AS IT WAS LEAKING. WHEN THE BALLOON CATHETER WAS INTRODUCED INTO THE SHEATH, THE SURGEON COMMENTED THAT HE COULD NOT GET THE SHEATH/LOADER CAP TO STOP BLEEDING AND THAT THERE WAS SOMETHING WRONG WITH THE HUB OF THE SHEATH. HE THEN BACKED THE LOADER CAP OFF OF THE SHEATH AND PROCEEDED TO INTRODUCE THE BALLOON CATHETER WITH THE SAPIEN VALVE. THE VALVE WAS POSITIONED AND DEPLOYED SUCCESSFULLY. BOTH THE SHEATH AND BALLOON CATHETER WERE REMOVED AND HANDED TO THE DEVICE PREP TABLE. THE DEVICE WAS CLEANED AND LOADED INTO THE SHEATH WITH THE LOADER CAP ATTACHED TO THE SHEATH BUT THEY COULD NOT VISIBLY SEE ANYTHING DEFECTIVE WITH THE SYSTEM. FURTHER CLARIFICATION REVEALED THE SURGEON HAD THE LOADER PULLED BACK OFF THE HUB OF THE SHEATH. THE FCS INITIALLY ASSUMED IT WAS THE LOADER THAT WAS NOT WORKING AND THAT WAS WHY THE PHYSICIAN PULLED IT OFF THE SHEATH. HOWEVER THE PHYSICIAN CLARIFIED THAT IT WAS THE HUB OF THE SHEATH THAT WAS LEAKING. THE FCS TOOK THE ENTIRE DELIVERY SYSTEM/SHEATH/LOADER CAP BACK TO THE TABLE BUT COULD NOT SEE ANYTHING OBVIOUSLY WRONG WITH THE HUB OF THE SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105345 ASCENDRA INTRODUCER SHEAT SET AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9100IS 59317300

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR