BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DECANAV ELECTROPHYSIOLOGY CATHETER

    MDR report key: 17962492 · Received October 18, 2023

    Report

    Report Number
    2029046-2023-02369
    Event Type
    Injury
    Date Received
    October 18, 2023
    Date of Event
    January 1, 2023
    Report Date
    October 18, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    UDI-DI
    10846835008791
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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: ÖZCAN ÇETIN EH, KARA M, KORKMAZ A, ÖZEKE Ö, ÇAY S, ÖZCAN F, TOPALOGLU S, ARAS D. INADVERTENT RIGHT VENTRICULAR APICAL EXIT AFTER STEREOTACTIC BODY RADIOTHERAPY FOR VENTRICULAR TACHYCARDIA: EVERY CLOUD HAS A SILVER LINING. ANATOL J CARDIOL. 2023 JAN;27(1):E1-E2. DOI: 10.14744/ANATOLJCARDIOL.2022.2384. PMID: 36680452; PMCID: PMC9893711. 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. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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. MANUFACTURER'S REF #: (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTION TO THE INITIAL MDR, NO UDI WAS PROVIDED WITHOUT AN EXPLANATION. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: ÖZCAN ÇETIN EH, KARA M, KORKMAZ A, ÖZEKE Ö, ÇAY S, ÖZCAN F, TOPALOGLU S, ARAS D. INADVERTENT RIGHT VENTRICULAR APICAL EXIT AFTER STEREOTACTIC BODY RADIOTHERAPY FOR VENTRICULAR TACHYCARDIA: EVERY CLOUD HAS A SILVER LINING. ANATOL J CARDIOL. 2023 JAN;27(1):E1-E2. DOI: 10.14744/ANATOLJCARDIOL.2022.2384. PMID: 36680452; PMCID: PMC9893711. CASE OF A 78 YO MALE UNDERGOING VENTRICULAR TACHYCARDIA (VT) ABLATION EXPERIENCES CARDIAC PERFORATION WITH DECANAV CATHETER. INTERPRETATION OF THE PUBLISHED SEQUENCE OF DETAILS ARE THE AUTHORS PLACED THE DECANV CATHETER IN THE APEX OF THE RV AND PERFORATED THE RV. SUBSEQUENTLY, THEY CONFIRMED THE LOCATION OF THE CATHETER IN THE EPI THROUGH FLUOROSCOPY. POSTERIORLY, THEY PLACED A PERCUTANEOUS DRAINAGE AND DECIDED TO CONVERT FROM A ENDO ABLATION TO A ENDO-EPI ABLATION. THEN, THEY PLACED A SECOND PERCUTANEOUS DRAINAGE AND INSERTED A SHEATH (¿MOBICATH SEATH¿). AFTERWARDS, THEY PULLED BACK THE DECANAV (WITH THE SHEATH OF THE DECANAV) WHILE THE SECOND DRAINAGE WAS KEPT TO CONTROL IF THERE WAS STILL PERICARDIAL EFFUSION. THE AUTHORS DO NOT PROVIDE IDENTITIES OF ALL THE PRODUCTS USED IN THE CASE. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DECANAV. OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A. NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: MOBICATH SHEATH. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: QTY 1 (CARDIAC PERFORATION) REQUIRING USE OF OTHER DEVICES TO INTERVENE (SERIOUS INJURY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93827 DECANAV ELECTROPHYSIOLOGY CATHETER CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC 10846835008791

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L MOBICATH SHEATH.