MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC (IRWINDALE) NAVISTAR? ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING

Model Number NAVISTAR TC

Device Problems Device Displays Incorrect Message (2591); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/27/2014

Event Type  malfunction  

Event Description

It was reported during an afib - paroxysmal that error 8 appeared on the carto3 system when the ablation catheter was connected, the signal noise occurred on all the channels, including the 12 leads of bs ecgs and all ic (intracardiac) recordings on both carto and ep recording systems at the same time and a red light on ecg card # 3 on back of piu.The physician did not have at least one signal available to monitor patient heart rhythm.The customer exchanged the ablation cable and rebooted the piu without resolution (when the cable was disconnected the noise resolved).Advised a full system reboot without catheters connected, the system fully initialized when a new study was started, error 8 did not return.Advised reconnecting ecg cable, connecting a new map cable (only reprocessed available), and connecting a new map catheter.Error 8 did not return and signals were clean on both carto and ep recording systems.The case was completed without any patient consequence.This event initially reported under the carto system with report # 3008203003-2014-00044.However, after investigation on (b)(4) 2014, biosense webster engineering confirmed that once a new mapping catheter was connected to the system, error 8 did not return, and signals became clean on both systems carto 3 and ep recording systems.The system is ready for use.The issue was related to defective mapping catheter.Multiple attempts have been made to obtain clarification to mapping catheter information.However, no further information has been made available.

Manufacturer Narrative

(b)(4).

• Brand Name: NAVISTAR? ELECTROPHYSIOLOGY CATHETER
• 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: 3958835
• MDR Text Key: 4622913
• Report Number: 2029046-2014-00213
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990025
• 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: 05/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NAVISTAR TC
• Device Lot Number: UNKNOWN_NAVISTAR TC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/27/2014
• Initial Date FDA Received: 07/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1