BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 3010773 · Received March 19, 2013

    Report

    Report Number
    2029046-2013-00036
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 5, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    DRF
    PMA / PMN Number
    P990025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONCOMITANT PRODUCTS: CARTO 3 RMT SYSTEM: MODEL # M-5830-01, SERIAL # (B)(4). STOCKERT 70 SYSTEM: MODEL # M-5463-01, SERIAL # (B)(4). COOLFLOW PUMP: MODEL # M-5491-02, SERIAL # (B)(4). (B)(4).

    Additional Manufacturer Narrative · 1

    AFTER MULTIPLE FOLLOW-UPS TO RETRIEVE THE CATHETER, NO CATHETER WAS RETURNED. THEREFORE NO EVALUATION WAS PERFORMED. ON (B)(6), CUSTOMER CONFIRMED THAT THE EVENT WAS NOT PERICARDIAL EFFUSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN EPICARDIAL IDIOPATHIC VT CASE THE PATIENT BECAME HYPOTENSIVE. DUE TO THE TCOOL CATHETER IN USE, PHYSICIAN ALREADY HAD THE PERICARDIUM CANNULATED AND A SMALL AMOUNT (PRECISE AMOUNT UNKNOWN) OF FLUID WAS DRAINED. HYPOTENSION WAS RESOLVED, AND PATIENT WAS STABLE THROUGHOUT THE REMAINDER OF THE CASE. CASE WAS COMPLETED WITHOUT FURTHER INCIDENT, AND PATIENT WAS ADMITTED FOR OBSERVATION IN STABLE CONDITION. SINCE THIS WAS AN EPICARDIAL VT, PERICARDIAL PUNCTURE WAS PERFORMED THE PHYSICIAN'S OPINION REGARDING THE CAUSALITY OF THIS EVENT WAS A POSSIBLE INJURED PERIPHERAL ARTERY DURING TRANS XIPHOIDEUS PUNCTURE. THE ANTERIOR VEIN MAY HAVE DRAINED TO THE PERICARDIAL SPACE. ALSO THERE WAS A POSSIBILITY THAT A HEMATOMA WAS FORMED IN THE RIGHT ATRIUM POSTERIOR WALL AND CAUSES THE DROP IN THE BLOOD PRESSURE. ONCE THE HEMATOMA WAS DRAINED THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113175 NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER CATHETER, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC (IRWINDALE) NAVISTAR TC UNKNOWN_NAVISTAR TC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| O| R