BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOBALLOON ABLATION SYSTEM

    MDR report key: 14361748 · Received May 11, 2022

    Report

    Report Number
    3008780134-2022-00003
    Event Type
    Injury
    Date Received
    May 11, 2022
    Date of Event
    March 14, 2022
    Report Date
    October 18, 2022
    Manufacturer
    PENTAX OF AMERICAS, INC.
    Product Code
    GEH
    UDI-DI
    00854924006286
    PMA / PMN Number
    K190194
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF) ADVERSE EVENT REPORTING: (B)(4). PENTAX MEDICAL WAS NOTIFIED OF THE (B)(6) 2022 EVENT ON (B)(6) 2022, WEEKS AFTER THE EVENT OCCURRED. THE PRODUCTS HAD BEEN REPORTED AS DISCARDED PRIOR TO PENTAX MEDICAL BEING NOTIFIED AND WERE NOT AVAILABLE FOR EVALUATION. THE CONTROLLER AND FOOT PEDAL ARE REUSABLE PRODUCTS AND WHILE THEY HAVE NOT BEEN RETURNED FOR EVALUATION, FOLLOW UP FOR THE RETURN OF THE DEVICES IS BEING PERFORMED SO THE INVESTIGATION REMAINS IN-PROCESS. SINCE THE SERIAL AND/OR LOT NUMBERS OF THE DEVICES WER NOT REPORTED, A SERIAL/LOT HISTORY RECORD REVIEWS COULD NOT BE COMPLETED FOR THE PRODUCTS. IF THE PRODUCTS ARE RETURNED AND THE SERIAL AND/OR LOT NUMBERS BECOME AVAILABLE, THE HISTORY REVIEWS WILL BE COMPLETED. MDR 3008780134-2022-00004 IS BEING SUBMITTED FOR THE PENTAX MEDICAL GEN 2 CONTROLLER, MODEL FG-1017, UNKNOWN SERIAL NUMBER. MDR 3008780134-2022-00005 IS BEING SUBMITTED FOR THE PENTAX MEDICAL GEN 2 FOOT PEDAL, MODEL FG-1018, UNKNOWN LOT NUMBER.

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURER NARRATIVE AND CORRECTED DATA: B4: UPDATED DATE OF THIS REPORT WITH TODAYS DATE B5: ADDED REFERENCE TO REFER TO H10 G6: TYPE OF REPORT UPDATED AND UPDATED H6: CONTINUED: INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF) ADVERSE EVENT REPORTING COMPONENT CODE: REMOVE: 819 FOOT PEDAL, 765 CONTROLLER, ADD: CATHETER 3038 TYPE OF INVESTIGATION: REMOVE: 4118 TYPE OF INVESTIGATION NOT YET DETERMINED, ADD: 4114 DEVICE NOT RETURNED INVESTIGATION FINDINGS: REMOVE: 3233 RESULTS PENDING COMPLETION OF INVESTIGATION, ADD: 3221 NO FINDINGS AVAILABLE INVESTIGATION CONCLUSIONS: REMOVE: 11 CONCLUSION NOT YET AVAILABLE, ADD: 4315 CAUSE NOT ESTABLISHED THE C2 CRYOBALLOON ABLATION SYSTEM IS INTENDED FOR USE AS A CRYOSURGICAL TOOL IN THE FIELD OF GENERAL SURGERY, SPECIFICALLY FOR ENDOSCOPIC APPLICATIONS, TO INCLUDE ABLATION OF BARRETT'S ESOPHAGUS WITH DYSPLASIA. ALTHOUGH COVERED BY GENERAL INDICATION THE DEVICE IS NOT CLEARED FOR SPECIFIC USE OF SQUAMOUS TISSUE. THE PHYSICIAN CHOSE TO USE THIS DEVICE ON A MEDICAL CONDITION COVERED UNDER THE GENERAL INDICATION FOR THE DEVICE. ALTHOUGH THE PATIENT INJURY WAS CONFIRMED, SINCE THE DEVICES WERE NOT RETURNED OR IDENTIFIED, THERE WAS NO EVALUATION PERFORMED ON THE PRODUCT AND NO INDICATION THE DEVICES MALFUNCTIONED OR FAILED TO MEET SPECIFICATION. BASED ON THE INVESTIGATION THE EXACT CAUSE OF THE USER'S EXPERIENCE DURING TREATMENT REMAINS WAS NOT ESTABLISHED AND REMAINS UNKNOWN. PENTAX MEDICAL HAS NOT RECEIVED ANY FURTHER INFORMATION FOR THIS EVENT AND THEREFORE, CONSIDERS THIS MEDWATCH REPORT CLOSED. MDR IS BEING SUBMITTED FOR THE PENTAX MEDICAL GEN 2 FOCAL STANDARD CATHETER, MODEL FG-1028, UNKNOWN LOT NUMBER. MDR 3008780134-2022-00004 IS BEING SUBMITTED FOR THE PENTAX MEDICAL GEN 2 CONTROLLER, MODEL FG-1017, UNKNOWN SERIAL NUMBER. MDR 3008780134-2022-00005 IS BEING SUBMITTED FOR THE PENTAX MEDICAL GEN 2 FOOT PEDAL, MODEL FG-1018, UNKNOWN LOT NUMBER.

    Description of Event or Problem · 0

    PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT ON (B)(6) 2022 THAT OCCURRED IN THE OPERATING ROOM DURING USE IN THE UNITED STATES. PER THE INITIAL CUSTOMER REPORT, THE PHYSICIAN ADVANCED THE BALLOON INTO A PATIENT'S ESOPHAGUS, AND AUTOMATICALLY INFLATED BALLOON WITH THE FOOT PEDAL, WHICH RESULTED IN A PERFORATION OF THE ESOPHAGUS, INVOLVING PENTAX MEDICAL C2 CRYOBALLOON ABLATION SYSTEM, FOCAL STANDARD CATHETER MODEL FG-1028, USED WITH CRYOBALLOON CONTROLLER MODEL FG-1017 AND CRYOBALLOON FOOT PEDAL MODEL FG-1018. LOT AND SERIAL NUMBERS ARE UNKNOWN FOR ALL PRODUCTS. THE PATIENT WAS SENT TO SURGERY AND UNDERWENT ESOPHAGECTOMY AND REPAIR OF THE PERFORATION. THE PATIENT DID WELL AND WAS DISCHARGED HOME. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 0

    REFER TO H10

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1789747 CRYOBALLOON ABLATION SYSTEM GEN 2 FOCAL STANDARD CATHETER GEH PENTAX OF AMERICAS, INC. FG-1028 UNKNOWN 00854924006286

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Other