BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCEND® AQ® URETERAL BALLOON CATHETER

    MDR report key: 6263620 · Received January 19, 2017

    Report

    Report Number
    1820334-2017-00138
    Event Type
    Malfunction
    Date Received
    January 19, 2017
    Date of Event
    December 14, 2016
    Report Date
    March 27, 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, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE DEVICE IS SHIPPED WITH AN INSTRUCTION FOR USE (IFU) THAT DESCRIBES THE INTENDED USE, SPECIFIC ITEMS ARE ADDRESSED SUCH AS: BALLOON DILATION CATHETERS ARE INTENDED FOR USE BY PHYSICIAN TRAINED AND EXPERIENCED IN TECHNIQUES FOR BALLOON CATHETER DILATION. DO NOT EXCEED THE MAXIMUM RATED BURST PRESSURE (LISTED ON LABEL) FOR THIS BALLOON DEVICE. DO NOT PREINFLATE THE BALLOON. REFER TO PRODUCT LABEL OR THE INFLATION CHECK VALVE ON THE BALLOON DEVICE FOR APPROPRIATE BALLOON VOLUME. THE BURST PRESSURE DATA WAS ANALYZED USING FACTORS FOR A ONE-SIDED TOLERANCE TO DETERMINE WITH 95% CONFIDENCE THAT 99.9% OF THESE BALLOONS WOULD NOT BURST AT OR BELOW THE CALCULATED RATED BURST PRESSURE. THE VISUAL INSPECTION OF THE RETURNED DEVICES REPORTED: 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 AS WELL AS THERE ARE NO OTHER COMPLAINTS ASSOCIATED WITH THE THREE POSSIBLE LOT NUMBERS FOR THIS COMPLAINT. 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. BASED ON THE INFORMATION PROVIDED, AND THE RESULTS OF OUR INVESTIGATION, NONE OF THE THREE ASSOCIATED LOTS REVEAL ANY RELEVANT MANUFACTURING DEFECTS THAT COULD HAVE CONTRIBUTED TO THIS FAILURE. 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 NO PATIENT CONTACT. 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
    46241 ASCEND® AQ® URETERAL BALLOON CATHETER EZN DILATOR, CATHETER, URETERAL EZN COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1