BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCEND® AQ® URETERAL BALLOON CATHETER

    MDR report key: 6263400 · Received January 19, 2017

    Report

    Report Number
    1820334-2017-00137
    Event Type
    Malfunction
    Date Received
    January 19, 2017
    Date of Event
    December 14, 2016
    Report Date
    March 17, 2017
    Manufacturer
    COOK INC
    Product Code
    EZN
    PMA / PMN Number
    K040127
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION - EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, FUNCTIONAL TEST, DEVICE HISTORY RECORD, QUALITY CONTROL AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE VISUAL INSPECTION OF THREE DIFFERENT LOT NUMBERS WERE REPORTED AS FOLLOWED: LOT #6980348: ONE USED BALLOON CATHETER WAS RETURNED FOR INVESTIGATION. A VISUAL EXAMINATION NOTED THE BALLOON HAS A YELLOW DISCOLORATION. THE BALLOON MATERIAL WAS ALSO NOTED TO HAVE PINCHED MARK LOCATED 4-5 CM FROM THE DISTAL TIP. THE TOTAL LENGTH OF THE BALLOON CATHETER MEASURED 68.5 CM. A FUNCTIONAL TEST WAS PERFORMED AND THE BALLOON FILLED WITH AIR, NO RUPTURE WAS IDENTIFIED. LOT # 6327410: ONE USED BALLOON CATHETER WAS RETURNED FOR INVESTIGATION. A VISUAL EXAMINATION NOTED THE BALLOON HAS A YELLOW DISCOLORATION. . THE TOTAL LENGTH OF THE BALLOON CATHETER MEASURED 68.5 CM. A FUNCTIONAL TEST WAS PERFORMED AND THE BALLOON FILLED WITH AIR, NO LEAKS OBSERVED. USING WATER, THE BALLOON WAS INFLATED, STILL NO LEAKS NOTED. THE BALLOON HAD NO NOTABLE DAMAGE OR PINCH MARKS. THE BALLOON DEFLATED FINE. LOT #6816021: ONE USED BALLOON CATHETER WAS RETURNED FOR INVESTIGATION. THE BALLOON WAS NOTED TO HAVE LIQUID IN IT BUT IT WAS NOT FULLY INFLATED. A VISUAL EXAMINATION NOTED THE BALLOON HAS A YELLOW DISCOLORATION. THE BALLOON MATERIAL WAS ALSO NOTED TO HAVE PINCHED MARK LOCATED 4-5 CM FROM THE DISTAL TIP. THE TOTAL LENGTH OF THE BALLOON CATHETER MEASURED 68.5 CM. A FUNCTIONAL TEST WAS PERFORMED BY USING WATER; A LEAK WAS NOTED BETWEEN THE ET BAND AND THE PROXIMAL BOND ON THE BALLOON MATERIAL. THE COMPLAINT DEVICE WAS RETURNED THEREFORE, AN INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF DEVICE HISTORY RECORD SHOWS A REVIEW OF NON-CONFORMANCES FROM THE THREE POSSIBLE LOT NUMBERS DID NOT REVEAL ANY RELEVANT MANUFACTURING DEFECTS THAT COULD HAVE CONTRIBUTED TO THIS FAILURE. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF OUR INVESTIGATION, THERE ARE NO OTHER COMPLAINTS ASSOCIATED WITH THE THREE POSSIBLE LOT NUMBERS FOR THIS COMPLAINT. NO CONCLUSION ON THE ROOT CAUSE CAN BE DETERMINED AT THIS TIME. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE USER FACILITY THAT THE DEVICE WAS USED FOR LAPAROSCOPIC COMMON BILE DUCT EXPLORATION INCLUDING CHOLECYSTECTOMY. THE USER KNEW THE DEVICE INTENDED USE FOR UROLOGICAL AREA; HOWEVER, HE USED IT FOR THIS PROCEDURE SINCE THERE WAS NO DESIRED SIZE OF THE BALLOON. THE DEVICE WAS INSERTED PERCUTANEOUSLY, BUT IT RUPTURED DURING USE IN THE BILE DUCT ((B)(4)). THEN, IT WAS CHANGED WITH ANOTHER DEVICE PRIOR TO PATIENT CONTACT TO TEST THE FUNCTION AND FOUND THAT THE BALLOON WOULD NOT INFLATE EITHER ((B)(4)). A THIRD DEVICE WAS INFLATED AS WELL, PRIOR TO PATIENT CONTACT TO TEST THE FUNCTION AND FOUND THAT THE BALLOON WOULD NOT INFLATE EITHER ((B)(4)). THE THIRD DEVICE WAS CHANGED WITH ANOTHER BALLOON AND THE PROCEDURE WAS COMPLETED. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. DUE TO THE REOCCURRENCES, TWO OTHER COMPLAINTS WHERE OPENED ((B)(4)) TO CAPTURE THE OTHER TWO FAILURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47688 ASCEND® AQ® URETERAL BALLOON CATHETER EZN DILATOR, CATHETER, URETERAL EZN COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1