BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    MDR report key: 3160445 · Received June 10, 2013

    Report

    Report Number
    9673241-2013-00183
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 14, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONCOMITANT PRODUCTS: CARTO 3: MODEL# M-4800-01, SERIAL# (B)(4). STOCKERT: MODEL# M-5463-01, SERIAL# (B)(4). COOLFLOW PUMP: MODEL# M-5491-02, SERIAL# (B)(4). LASSO NAV VARIABLE ECO: MODEL# D-1343-01-S, LOT# 15765135L. EZ STEER CORONARY SINUS: MODEL# D-1263-04-S, LOT# 15817706M. SOUNDSTAR: MODEL# M-5723-05, LOT# 10846835000139. PREFACE SHEATH: MODEL# 301803M, LOT# 15774268. (B)(4).

    Additional Manufacturer Narrative · 1

    AFTER MULTIPLE FOLLOW-UPS TO RETRIEVE THE CATHETER, NO CATHETER WAS RETURNED. THEREFORE NO EVALUATION WAS PERFORMED. THE DEVICE HISTORY RECORD WAS REVIEWED; THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, THE PATIENT'S HEART RATE INCREASED TO 165 BEATS PER MINUTE FOLLOWING A DOUBLE TRANSSEPTAL PUNCTURE. INTRACARDIAC ULTRASOUND IDENTIFIED A PERICARDIAL EFFUSION. TRANSTHORACIC ECHOCARDIOGRAPHY WAS USED TO CONFIRM THE PERICARDIAL EFFUSION. THE PHYSICIAN FELT THAT HIS FIRST OF THE TWO TRANSSEPTAL PUNCTURES WAS TOO POSTERIOR AND WHEN HE PUNCTURED FOR THE FIRST TRANSSEPTAL ACCESS, HE MAY HAD PERFORATED AT THAT TIME. THE PATIENT REQUIRED A PERICARDIOCENTESIS DUE TO TACHYCARDIA, HYPOTENSION & PULSUS PARADOXUS. PERICARDIOCENTESIS WAS BEING PERFORMED AND 150ML WERE REMOVED FROM THE PERICARDIUM. THE PHYSICIAN STATED THAT THE PATIENT'S HEART WAS ROTATED, BUT HE DID NOT STATE THAT HE FELT IT WAS THE CAUSE OF THE PERFORATION. THIS INCIDENT OCCURRED PRIOR TO MAPPING FOR THE GEOMETRY AND NO POWER WAS DELIVERED. THE PATIENT WAS GIVEN AN INITIAL BOLUS OF HEPARIN (UNKNOWN DOSE) JUST SECONDS BEFORE THE PATIENT EXHIBITED SIGNS OF INCIDENT. THE EVENT REQUIRED HOSPITALIZATION BY ONE DAY. THE RETURNED DEVICE WAS VISUALLY INSPECTED UPON RECEIPT AND IT WAS FOUND IN NORMAL CONDITIONS. PER THE EVENT, THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE, TEMPERATURE RESPONSE AND STOCKERT COMPATIBILITY AND IT WAS FOUND WITHIN SPECIFICATIONS. FURTHERMORE, A COOL FLOW PUMP TEST WAS PERFORMED AND THE CATHETER PASSED SPECIFICATIONS. THE CATHETER WAS ALSO EVALUATED FOR EEPROM, CARTO 3, 4 KHZ AND CALIBRATION FUNCTIONALITY. THE CATHETER WAS RECOGNIZED BY CARTO 3 SYSTEM, NO ERROR MESSAGES WERE DISPLAYED AND THE CATHETER WAS PROPERLY VISUALIZED. EEPROM DATA DEMONSTRATES THE CATHETER WAS PROPERLY CALIBRATED DURING MANUFACTURING. FINALLY, A DEFLECTION TEST WAS PERFORMED AND THE CATHETER PASSED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THE CATHETER PASSED ALL SPECIFICATIONS. THE ROOT CAUSE OF THE PERICARDIAL EFFUSION REMAINS UNKNOWN. THE IFU STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION OR TAMPONADE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, THE PATIENT'S HEART RATE INCREASED TO 165 BEATS PER MINUTE FOLLOWING A DOUBLE TRANSSEPTAL PUNCTURE. INTRACARDIAC ULTRASOUND IDENTIFIED A PERICARDIAL EFFUSION. TRANSTHORACIC ECHOCARDIOGRAPHY WAS USED TO CONFIRM THE PERICARDIAL EFFUSION. THE PHYSICIAN FELT THAT HIS FIRST OF THE TWO TRANSSEPTAL PUNCTURES WAS TOO POSTERIOR AND WHEN HE PUNCTURED FOR THE FIRST TRANSSEPTAL ACCESS, HE MAY HAD PERFORATED AT THAT TIME. THE PATIENT REQUIRED A PERICARDIOCENTESIS DUE TO TACHYCARDIA, HYPOTENSION AND PULSUS PARADOXUS. PERICARDIOCENTESIS WAS BEING PERFORMED AND 150ML WERE REMOVED FROM THE PERICARDIUM. THE PHYSICIAN STATED THAT THE PATIENT'S HEART WAS ROTATED, BUT HE DID NOT STATE THAT HE FELT IT WAS THE CAUSE OF THE PERFORATION. THIS INCIDENT OCCURRED PRIOR TO MAPPING FOR THE GEOMETRY AND NO POWER WAS DELIVERED. THE PATIENT WAS GIVEN AN INITIAL BOLUS OF HEPARIN (UNKNOWN DOSE) JUST SECONDS BEFORE THE PATIENT EXHIBITED SIGNS OF INCIDENT. THE EVENT REQUIRED HOSPITALIZATION BY ONE DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259421 THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1313-04-S 15750677L

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R