BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK BALLOON CATHETER

    MDR report key: 13518479 · Received February 11, 2022

    Report

    Report Number
    3008114965-2022-00108
    Event Type
    Injury
    Date Received
    February 11, 2022
    Date of Event
    September 23, 2011
    Report Date
    February 11, 2022
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    MJN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE CITATION IS AS FOLLOWS: SCIENTIFIC PAPER SESSIONS. FRIDAY, SEPTEMBER 23RD, 2011 ¿ ANTWERP ROOM. NEURORADIOLOGY (2011) 53 (SUPPL 1):S17¿S71 DOI 10.1007/S00234-011-0914-7. THIS COMPLAINT SPECIFICALLY CAPTURES THE ABSTRACT ON PAGE S68 ENTITLED ¿DOUBLE LUMEN REMODELING BALLOON: NEW TOOL FOR ¿CLASSIC¿ BALLOON ASSISTED COILING TECHNIQUE AND FOR ¿NOVEL¿ DIRECT BALLOON CATHETER COILING TECHNIQUES¿ K. KADZIOLKA, W. MUSTAFA, A. LEAUTAUD, L. ESTRADE, L. PIEROT. THE PRODUCT CATALOG AND LOT NUMBERS ARE NOT AVAILABLE / NOT REPORTED. THE UNIQUE IDENTIFIER (UDI) AND EXPIRATION DATE OF THE DEVICE IS NOT KNOWN. THE NAME, PHONE AND EMAIL ADDRESS OF THE INITIAL REPORTER ARE NOT AVAILABLE / REPORTED. THE DEVICE MANUFACTURE DATE IS NOT KNOWN AS THE DEVICE LOT NUMBER IS NOT AVAILABLE / NOT REPORTED. DUE TO THE NATURE OF THE COMPLAINT, THE DEVICE (S) WERE NOT RETURNED FOR ANALYSIS NOR WAS THE STERILE LOT NUMBERS PROVIDED IN ORDER TO CONDUCT A LOT HISTORY REVIEW. AS A RESULT, WE ARE CLOSING THIS INVESTIGATION. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. SINCE THE ACTUAL SEVERITY OF THE INTRAOPERATIVE VASOSPASM EVENTS IS UNKNOWN AND THE RELATIONSHIP OF THE ASCENT BALLOON TO THE EVENTS CANNOT BE DISASSOCIATED, THE EVENTS WILL BE CONSERVATIVELY REPORTED TO THE FDA WITH THE CLASSIFICATION OF ¿SERIOUS INJURY¿. THERE IS NO INDICATION THAT THE EVENTS WERE RELATED TO A DEVICE DESIGN OR MANUFACTURING ISSUE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE CITATION IS AS FOLLOWS: SCIENTIFIC PAPER SESSIONS. FRIDAY, SEPTEMBER 23RD, 2011 ¿ ANTWERP ROOM. NEURORADIOLOGY (2011) 53 (SUPPL 1):S17¿S71 DOI 10.1007/S00234-011-0914-7. THIS COMPLAINT SPECIFICALLY CAPTURES THE ABSTRACT ON PAGE S68 ENTITLED ¿DOUBLE LUMEN REMODELING BALLOON: NEW TOOL FOR ¿CLASSIC¿ BALLOON ASSISTED COILING TECHNIQUE AND FOR ¿NOVEL¿ DIRECT BALLOON CATHETER COILING TECHNIQUES¿ K. KADZIOLKA, W. MUSTAFA, A. LEAUTAUD, L. ESTRADE, L. PIEROT. OBJECTIVE AND METHODS: THE ABSTRACT DESCRIBES PRELIMINARY EXPERIENCE IN USE OF DOUBLE LUMEN REMODELING BALLOON FOR ENDOVASCULAR TREATMENT OF LARGE NECK INTRACRANIAL ANEURYSMS. 24 PATIENTS WITH LARGE NECK INTRACRANIAL ANEURYSMS WERE TREATED WITH USE OF DOUBLE LUMEN REMODELING BALLOON ASCENT AT A SINGLE INSTITUTION. LOT, MODEL OR CATALOG NUMBERS ARE NOT AVAILABLE, BUT THE SUSPECTED CERENOVUS DEVICE (S) POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: ASCENT BALLOON CATHETER. CONCOMITANT CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: NI. CONCOMITANT NON-CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: NI. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: THERE WAS ONE CASE OF SAC PERFORATION WITHOUT CLINICAL CONSEQUENCES. THERE WERE 2 CASES OF INTRAOPERATIVE VASOSPASM DUE TO CHALLENGING NAVIGATION OF THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883828 UNK BALLOON CATHETER CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY MJN MEDOS INTERNATIONAL SARL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other