BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER

    MDR report key: 11709324 · Received April 22, 2021

    Report

    Report Number
    1820334-2021-01202
    Event Type
    Malfunction
    Date Received
    April 22, 2021
    Date of Event
    July 22, 2019
    Report Date
    April 22, 2021
    Manufacturer
    COOK INC
    Product Code
    LKF
    UDI-DI
    00827002171473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER NAME AND ADDRESS- PHONE: (B)(6). PMA/510(K) #- K180291. EVENT SUMMARY: AS REPORTED, DURING A HYSTEROSONOGRAPHY PROCEDURE, A COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER RUPTURED. THE DEVICE WAS TESTED PRIOR TO THE PROCEDURE USING THE PROVIDED 1ML SYRINGE, AND BALLOON WAS BROKEN. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT ANY COMPLICATIONS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. INVESTIGATION - EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE, SPECIFICATIONS, AND QUALITY CONTROL PROCEDURES AND A VISUAL INSPECTION OF THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. TWO OPEN PACKAGES EACH CONTAINING A COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER WERE RETURNED FOR INVESTIGATION. VISUAL EXAMINATION CONFIRMED TWO BALLOON CATHETERS WERE RECEIVED IN A USED CONDITION. THE FIRST CATHETER WAS BOWED STARTING 19.5CM FROM THE DISTAL TIP AND CONTINUED TO 28 CM FROM THE TIP. A FUNCTIONAL TEST WAS PERFORMED ON BY INFLATING THE BALLOONS WITH TAP WATER. THE BALLOON INFLATED AND DEFLATED PROPERLY AND WITHOUT INCIDENT. THE SECOND CATHETER WAS SEVERELY BENT 22.5CM FROM THE DISTAL TIP AND BOWED IN THREE LOCATIONS. THE EXTENSION TUBES WERE BENT APPROXIMATELY 2.3CM BEHIND THE MANIFOLD. THE BALLOON MATERIAL HAD A CURVED SPLIT STARTING AT THE DISTAL BOND. THE SHAPE OF THE SPLIT WAS INDICATIVE OF OVERINFLATION. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. NO RELATED NON-CONFORMANCES WERE RECORDED, AND THERE HAVE BEEN NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. THE DEVICE HISTORY RECORD REVIEW PROVIDES OBJECTIVE EVIDENCE THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NONCONFORMING DEVICES FROM THE COMPLAINT LOT IN HOUSE OR IN THE FIELD. CURRENT CONTROLS FOR MANUFACTURING ARE IN PLACE TO ASSURE FUNCTIONALITY AND DEVICE INTEGRITY PRIOR TO SHIPPING. REVIEW OF PRODUCTION AND QUALITY DOCUMENTATION DID NOT OBSERVE ANY SPECIFIC ISSUES WITH CURRENT MANUFACTURING OR QUALITY CONTROLS THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. THE DEVICE IS INCLUDED WITH INSTRUCTIONS FOR USE WHICH CAUTION, ¿DO NOT OVER INFLATE. USING EXCESSIVE PRESSURE TO INFLATE THE BALLOON ON THIS DEVICE CAN CAUSE THE BALLOON TO RUPTURE. REFER TO PRODUCT LABEL OR THE INFLATION CHECK VALVE ON THE BALLOON DEVICE FOR APPROPRIATE BALLOON VOLUME.¿ BASED ON THE AVAILABLE INFORMATION, COOK HAS CONCLUDED THAT THE MOST PROBABLE CAUSE OF THE BALLOON RUPTURE WAS THE OVERINFLATION OF THE BALLOON. COOK WILL CONTINUE MONITORING OF SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    AS REPORTED, DURING A HYSTEROSONOGRAPHY PROCEDURE, A COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER RUPTURED. THE DEVICE WAS TESTED PRIOR TO THE PROCEDURE USING THE PROVIDED 1ML SYRINGE, AND BALLOON WAS BROKEN. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT ANY COMPLICATIONS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604259 COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER LKF CANNULA, MANIPULATOR/INJECTOR, UTERINE LKF COOK INC G17147 9167775 00827002171473

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR