BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCEPTER XC

    MDR report key: 15756862 · Received November 8, 2022

    Report

    Report Number
    2032493-2022-00514
    Event Type
    Malfunction
    Date Received
    November 8, 2022
    Date of Event
    October 4, 2022
    Report Date
    October 25, 2022
    Manufacturer
    MICROVENTION
    Product Code
    DQY
    UDI-DI
    00842429103418
    PMA / PMN Number
    K121785
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SEARCH FOR NON-CONFORMANCES ASSOCIATED WITH THIS PART/LOT NUMBER COMBINATION DID NOT REVEAL ANY PRODUCTION-RELATED ISSUES RELEVANT TO THE COMPLAINT THAT OCCURRED DURING MANUFACTURING OF THE DEVICE. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION IS ONGOING. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL MDR WILL BE SUBMITTED. THE INSTRUCTION FOR USE (IFU) INCLUDE THE WARNINGS: DO NOT EXCEED THE MAXIMUM RECOMMENDED INFLATION VOLUME AS BALLOON RUPTURE MAY OCCUR. EXCESSIVE PRESSURE HIGHER THAN 300 PSI (2069KPA) MAY CAUSE LEAKAGE OR RUPTURE OF THE BALLOON CATHETER WORKING LUMEN.

    Additional Manufacturer Narrative · 0

    CORRECTION TO B4 DATE OF THIS REPORT: THE DATE 4 NOVEMBER 2023 IS A TYPOGRAPHICAL ERROR. THE CORRECT DATE IS 25 OCTOBER 2022, AND IT IS ADDED TO THIS REPORT.

    Additional Manufacturer Narrative · 0

    CORRECTION G4: A CORRECTION IS BEING SUBMITTED AS THE WRONG DATE (B)(6), 2023 WAS IDENTIFIED IN G4. THE CORRECT DATE SHOULD BE STATED AS (B)(6), 2023. THIS ERROR WAS FOUND ON MARCH 22, 2023.

    Additional Manufacturer Narrative · 0

    CORRECTION: ORIGINAL DEVICE PRODUCT CODE MJN IS WRONG. THE CORRECT DEVICE PRODUCT CODE IS DQY. THE INVESTIGATION OF THE RETURNED BALLOON CATHETER FOUND THE HUB OCCLUDED WITH MATERIAL CONSISTENT WITH DRIED CONTRAST FROM THE DEVICE PREPARATION. AFTER BYPASSING THE HUB, THE BALLOON WAS ATTEMPTED TO BE INFLATED. HOWEVER, THE INVESTIGATION FOUND A RUPTURE IN THE BALLOON RESULTING IN A LEAK, WHICH IS CONSISTENT WITH THE ALLEGED PRODUCT ISSUE. FURTHER INVESTIGATION FOUND A FIBROUS MATERIAL CONSISTENT WITH COTTON WITHIN THE BALLOON AT THE SITE OF THE RUPTURE; HOWEVER, THE INVESTIGATION COULD NOT DETERMINE WHEN THE COTTON MATERIAL ENTERED THE BALLOON OR WHAT THE COTTON MATERIAL ORIGINATED FROM. THE PHYSICAL EVALUATION OF THE DEVICE COULD NOT IDENTIFY THE CONDITIONS OR CIRCUMSTANCES THAT LED TO THE RUPTURE, BUT THE DAMAGE IS CONSISTENT WITH THE DEVICE EXPERIENCING FORCES OVER SPECIFICATION. THE FINDINGS FROM THIS INVESTIGATION HAVE BEEN COMMUNICATED TO QUALITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING TREATMENT USING A SCEPTER XC BALLOON, THE BALLOON INITIALLY HAD DIFFICULTY PRIMING DURING SET UP. WHEN THE BALLOON WAS INFLATED INSIDE THE PATIENT, IT RUPTURED. NO PATIENT INJURY OR ADVERSE REACTIONS OCCURRED.

    Description of Event or Problem · 0

    SEE H10

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2954066 SCEPTER XC OCCLUSION BALLOON CATHETER DQY MICROVENTION BC0411XC-ID-700 0000083037 00842429103418
    872256 SCEPTER XC OCCLUSION BALLOON CATHETER DQY MICROVENTION BC0411XC-ID-700 0000083037 00842429103418

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown