BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR® THERMOCOOL® ELECTROPHYSIOLOGY CATHETER

    MDR report key: 4194793 · Received October 22, 2014

    Report

    Report Number
    9673241-2014-00436
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    August 4, 2014
    Report Date
    September 22, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    OAD
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE 3500A REPORT SUBMITTED ON OCTOBER 22, 2014, IT WAS STATED THAT THE REPORTED CONCOMITANT PRODUCT OF LASSO VARIABLE CATHETER WAS A QUANTITY INVOLVED OF 2. AFTER, A CORRECTION WAS RECEIVED ON OCTOBER 22, 2014 STATING THAT THE QUANTITY INVOLVED WAS 1. (B)(4)

    Additional Manufacturer Narrative · 1

    ON 12/1/2014, BIOSENSE WEBSTER RECEIVED CONFIRMATION THAT STATED THIS EVENT DID NOT REQUIRE ANY MEDICAL/SURGICAL INTERVENTION NOR PROLONG HOSPITALIZATION. ALSO THERE WAS NO LIFE- THREATENING TO THE PATIENT OF THIS EVENT. THEREFORE THIS EVENT WAS NOT MDR REPORTABLE. (B)(4)

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED. THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. (B)(4). CONCOMITANT PRODUCT: LASSO VARIABLE CATHETER, MODEL #: D-1237-02-S, LOT #: 15944566L, QUANTITY 2. MANUFACTURER'S REF. NO: (B)(4).

    Description of Event or Problem · 1

    THIS EVENT WAS PART OF (B)(6). THE ABLATION CATHETER USED WAS THE NAVISTAR THERMOCOOL. IT WAS REPORTED THAT AFTER THE PROCEDURE, THE PATIENT HAD VASCULAR PSEUDOANEURISM (PSA). NO ADDITIONAL MEDICAL/SURGICAL INTERVENTION NOR PROLONG HOSPITALIZATION WERE REQUIRED. THE PATIENT FULLY RECOVERED. NO CLAIM OF PRODUCT MALFUNCTION. THE PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THIS ADVERSE EVENT IS THAT IT WAS PROCEDURE RELATED. PSA IS ONE OF THE MOST COMMON VASCULAR COMPLICATIONS OF CARDIAC AND PERIPHERAL ANGIOGRAPHIC PROCEDURES. THE MOST POSSIBLE CATASTROPHIC COMPLICATION OF PSA IS RUPTURE. THEREFORE THIS SERIOUS ADVERSE EVENT IS DETERMINED TO BE MDR REPORTABLE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671393 NAVISTAR® THERMOCOOL® ELECTROPHYSIOLOGY CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC. (JUAREZ) D-1197-17-S 15919232M

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening