BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_LASSO

    MDR report key: 12841276 · Received November 18, 2021

    Report

    Report Number
    2029046-2021-01998
    Event Type
    Injury
    Date Received
    November 18, 2021
    Date of Event
    October 1, 2021
    Report Date
    November 18, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: PATEL N, MARINER D, VIJAYARAMAN P. SUCCESSFUL PERCUTANEOUS EXTRACTION OF A CIRCULAR MAPPING CATHETER ENTRAPPED IN A CHIARI NETWORK. J INTERV CARD ELECTROPHYSIOL. 2021 OCT;62(1):213-214. DOI: 10.1007/S10840-020-00921-9. EPUB: 2021 JAN 5. PMID: 33398499. NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER'S REF #: (B)(4).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: PATEL N, MARINER D, VIJAYARAMAN P. SUCCESSFUL PERCUTANEOUS EXTRACTION OF A CIRCULAR MAPPING CATHETER ENTRAPPED IN A CHIARI NETWORK. J INTERV CARD ELECTROPHYSIOL. 2021 OCT;62(1):213-214. DOI: 10.1007/S10840-020-00921-9. EPUB: 2021 JAN 5. PMID: 33398499. OBJECTIVE/METHODS/STUDY DATA: CASE STUDY OF A 57 YEAR OLD MAN WHO UNDERWENT SUCCESSFUL PULMONARY VEIN ISOLATION. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: LASSO MAPPING CATHETER. OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A. NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: WHILE CREATING AN ELECTROANATOMIC RIGHT ATRIAL MAP, THE CATHETER WAS NOTED TO BE ENTRAPPED AT THE RIGHT ATRIUM-INFERIOR VENA CAVA JUNCTION (CHIARI NETWORK) - RELEASED BY A 20-MM CIRCULAR SNARE AND GLIDE WIRE WERE ADVANCED VIA THE RIGHT JUGULAR VEIN TO LOCK THE GLIDE WIRE AND THEN PULLING FROM BOTH FEMORAL AND JUGULAR ACCESS POINTS FREED THE CATHETER WITH A NETWORK OF FIBROUS TISSUE OF THE CHIARI NETWORK. NO COMPLICATIONS WERE OBSERVED. NO PATIENT HARMS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1737706 UNK_LASSO CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention