BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX MEDICAL

    MDR report key: 21832585 · Received April 14, 2025

    Report

    Report Number
    2518897-2025-00006
    Event Type
    Injury
    Date Received
    April 14, 2025
    Date of Event
    April 1, 2025
    Report Date
    June 9, 2026
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    EOQ
    UDI-DI
    04961333222209
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    F10 CONTINUED: INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF) ADVERSE EVENT REPORTING. HEALTH EFFECT - CLINICAL CODE : 3165 DEVICE EMBEDDED IN TISSUE OR PLAQUE. HEALTH EFFECT - IMPACT CODE : 4603 DELAY TO DIAGNOSIS, 4641 UNEXPECTED MEDICAL INTERVENTION. MEDICAL DEVICE PROBLEM CODE : 4008 MATERIAL SPLIT, CUT OR TORN. COMPONENT CODE : 419 BALLOON. ADDITIONAL INFORMATION THIS EVENT WAS REPORTED TO THE FRENCH COMPETENT AUTHORITY (ANSM) UNDER REPORT NUMBER (B)(4). THE MATERIOVIGILANCE NUMBER ASSIGNED TO THIS EVENT BY ANSM IS (B)(4). INVESTIGATION IS IN-PROCESS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION. 2518897-2025-00005_OE-A61_(B)(6) _BALLOON RUPTURED AND FELL INTO BODY.

    Additional Manufacturer Narrative · 0

    CORRECTION INFORMATION: B4: DATE OF THIS REPORT. B5. REFER TO H11. F7: FOLLOW UP #01. F11: UPDATED DATES. F13: UPDATED DATES. ADDITIONAL INFORMATION D4: D4: PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) CORRECTED. F9: AGE OF DEVICE. H11: EVALUATION SUMMARY. EVALUATION SUMMARY - EVENT THAT OCCURRED: A DEFECTIVE BALLOON WAS IDENTIFIED. - SUMMARY OF EVENTS THAT OCCURRED: BASED ON THE INVESTIGATION, THE DEFECTIVE BALLOONS WERE NOT RETAINED BY THE FACILITY, AND THE EXACT NUMBER OF AFFECTED UNITS COULD NOT BE CONFIRMED. A POTENTIAL ROOT CAUSE OF THIS ISSUE IS IMPROPER STORAGE CONDITIONS, WHICH MAY HAVE CAUSED THE BALLOONS TO LOSE ELASTICITY AND DEVELOP CRACKS. BASED ON THE TREND ANALYSIS, THERE IS NO SIGNIFICANT INCREASE OR UPWARD TREND IN REPAIR COMPLAINTS RELATED TO THIS FAILURE MODE/HAZARD. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED BY THE MANUFACTURER. THE REVIEW BY DHR CONFIRMED THAT THE INSTRUMENT WAS MANUFACTURED UNDER NORMAL CONDITIONS ON (B)(6) 2024, PASSED ALL REQUIRED INSPECTIONS, AND WAS RELEASED ACCORDINGLY. ALSO, THERE WERE NO REWORKS OR CONCESSIONS, AND THE DATES OF APPROVAL FOR SHIPMENT AND ACTUAL DATE SHIPPED WERE CONFIRMED ON 06-AUG-2024. BASED ON THE TREND ANALYSIS, THERE IS NO SIGNIFICANT INCREASE OR UPWARD TREND IN REPAIR COMPLAINTS RELATED TO THIS FAILURE MODE/HAZARD. PENTAX MEDICAL HAS NOT RECEIVED ANY FURTHER INFORMATION FOR THIS EVENT AND THEREFORE, CONSIDERS THIS MEDWATCH REPORT CLOSED.BODY.

    Description of Event or Problem · 0

    ON 04-APR-2025, PENTAX MEDICAL BECAME AWARE OF AN EVENT INVOLVING A MODEL OE-A61, LOT NUMBER 1011084 BALLOON WITHIN (B)(6) IN THE EMEA REGION. DURING A PROCEDURE USING AN ULTRASOUND BRONCHOSCOPE, THE BALLOON AT THE DISTAL END RUPTURED. SINCE THE RUPTURED BALLOON WAS VISIBLE, IT WAS IMMEDIATELY REMOVED USING THE ENDOSCOPE. THIS RESPONSE EXTENDED THE PROCEDURE TIME AND THE PATIENT'S ANESTHESIA TIME. THE FACILITY DISCONTINUED THE USE OF BALLOONS FROM THE SAME LOT AND REPORTED THE EVENT TO PENTAX MEDICAL AND ANSM. THERE WAS NO REPORT OF PATIENT HARM. 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 H11.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1079487 PENTAX MEDICAL BALLOON EOQ HOYA CORPORATION PENTAX TOKYO OFFICE OE-A61 1011084 04961333222209

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention