BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTARAY NAV HIGH-DENSITY MAPPING CATHETER

    MDR report key: 15592862 · Received October 13, 2022

    Report

    Report Number
    2029046-2022-02506
    Event Type
    Injury
    Date Received
    October 13, 2022
    Date of Event
    February 27, 2021
    Report Date
    October 12, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    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. LOPES J, SOUSA PA, ELVAS L, GONÇALVES L. SUCCESSFUL RETRIEVAL OF A BROKEN PENTARAY CATHETER SPINE IN A PATIENT WITH MECHANIC MITRAL VALVE PROSTHESIS. J INTERV CARD ELECTROPHYSIOL. 2021 SEP;61(3):625-626. DOI: 10.1007/S10840-021-00965-5. EPUB 2021 FEB 27. PMID: 33638778. SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY BIOSENSE WEBSTER INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, BIOSENSE WEBSTER INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. LOPES J, SOUSA PA, ELVAS L, GONÇALVES L. SUCCESSFUL RETRIEVAL OF A BROKEN PENTARAY CATHETER SPINE IN A PATIENT WITH MECHANIC MITRAL VALVE PROSTHESIS. J INTERV CARD ELECTROPHYSIOL. 2021 SEP;61(3):625-626. DOI: 10.1007/S10840-021-00965-5. EPUB 2021 FEB 27. PMID: 33638778. OBJECTIVE/METHODS/STUDY DATA: THIS CASE DEMONSTRATES THAT ALTHOUGH RARE, PENTARAY ENTRAPMENT IN MECHANICAL VALVES IS STILL A DANGEROUS COMPLICATION DESPITE CAREFUL MAPPING. A 62-YEAR-OLD MAN WAS REFERRED FOR ABLATION OF ATYPICAL AFL.. HE ALREADY WAS SUBMITTED TO A PERSISTENT ATRIAL FLUTTER ABLATION. HE HAD PREVIOUSLY UNDERGONE MITRAL VALVE REPLACEMENT DUE TO SEVERE MITRAL REGURGITATION WITH A MECHANICAL BILEAFLET VALVE (ST. JUDE MEDICAL HEART VALVE: ST. JUDE MEDICAL AND ABOTT). ELECTROANATOMICAL ACTIVATION MAP WAS PERFORMED WITH THE CARTO 3 SYSTEM (BIOSENSE WEBSTER) AND WAS CONSISTENT WITH A COUNTERCLOCKWISE MITRAL AFL. DESPITE CAREFUL MAPPING NEAR THE MECHANICAL MITRAL VALVE, ONE OF THE SPINES OF THE PENTARAY CATHETER WAS ENTRAPPED IN THE PROSTHESIS. GENTLE ROTATION IN THE OPPOSITE DIRECTION AND TRACTION WAS PERFORMED BUT WITH AN UNSUCCESSFUL RESULT. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: PENTARAY CATHETER OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: CARTO 3 NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: STEERABLE SHEATH (AGILIS NXT, ST JUDE MEDICAL), EXPRO ELITE SNARE (TELEFLEX), ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS QTY 1 PENTARAY CATHETER WAS ENTRAPPED IN THE PROSTHESIS , THE LOST SPINE WAS CAUGHT WITH THE SNARE AND SUCCESSFUL REMOVED FROM THE LEFT ATRIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2271485 PENTARAY NAV HIGH-DENSITY MAPPING CATHETER CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other CARTO 3| EXPRO ELITE SNARE (TELEFLEX)| STEERABLE SHEATH (AGILIS NXT, ST JUDE MEDICAL)