MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC (IRWINDALE) CELSIUS THERMO TC; CATHETER, ELECTRODE RECORDING

Model Number CELSIUS THERMO TC

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Cardiac Perforation (2513)

Event Date 01/01/2013

Event Type  Injury  

Event Description

Initially the customer reported on (b)(6) 2014 that during a procedure, the customer had issues with t9 hardware errors, impedance errors, temperature errors when they used the stockert with ensite velocity system (cardiac mapping system- st.Jude).The customer stated these errors originally were only related to use with the ensite velocity systems but the customer noticed these issue on carto3 cases at a high frequency.The procedure was completed successfully without any patient consequent.In the same complaint, the customer stated that they also had a case last year with a celsius catheter and ensite velocity system, with the result of a cardiac perforation.This event was not reported to biosense webster.Therefore the awareness date is (b)(6) 2014.Multiple attempts were done to request for further details of this adverse event.However no additional information has been provided.

Manufacturer Narrative

(b)(4).

• Brand Name: CELSIUS THERMO TC
• Type of Device: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER, INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer (Section G): BIOSENSE WEBSTER, INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: jaime chavez ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 3911031
• MDR Text Key: 4588584
• Report Number: 2029046-2014-00188
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CELSIUS THERMO TC
• Device Lot Number: UNKNOWN_CELSIUS THERMO TC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/04/2014
• Initial Date FDA Received: 07/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention