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

Model Number D-1183-08-S

Device Problems Failure to Select Signal (1582); Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896)

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

Event Date 11/16/2016

Event Type  malfunction  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such, the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.Since no lot number was provided, no device history record (dhr) review could be performed.(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with a thermocool navistar catheter where a magnetic sensor error and complete signal loss were encountered.During the procedure, the catheter gave a magnetic sensor error.Additionally, signal was lost on all body surface and intracardiac channels.At the time, the physician did not have any available electrocardiograms (ecgs) to monitor the patient¿s heart rhythm.The catheter was replaced with one of the same type, and the procedure was completed without any report of patient consequence.A magnetic sensor error is highly detectable, and the possibility that it could cause or contribute to a serious injury or death is remote.However, the inability to monitor a patient¿s ecg rhythm while devices are intracardiac could lead to an undetected cardiac rhythm that could be life threatening.As a result, this event is mdr reportable.

Manufacturer Narrative

On 1/2/2017, biosense webster was informed that the catalog and lot number were initially misreported.As a result, the relevant fields have been updated.The bwi failure analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.(b)(4).

Manufacturer Narrative

(b)(4) it was reported that a patient underwent an ablation procedure with a thermocool navistar catheter where a magnetic sensor error and complete signal loss were encountered.The returned device was visually inspected, and was found in good condition.Per the reported event, the catheter was tested for electrical performance, and it was found within specifications.In addition, the catheter was evaluated for eeprom, carto 3 system performance and sensor functionality.The catheter was recognized by the carto 3 system with no error messages and proper visualization.Eeprom data demonstrates that the catheter was properly calibrated during manufacturing.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 customer complaint cannot be confirmed.The root causes of the signal issue and magnetic sensor error cannot be confirmed.

• 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. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua CA 32599 ; MX 32599
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6154586
• MDR Text Key: 62334786
• Report Number: 2029046-2016-00254
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P990025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/16/2016

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 Expiration Date: 01/31/2019
• Device Model Number: D-1183-08-S
• Device Catalogue Number: NS7TCFL174HS
• Device Lot Number: 17425545M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/15/2016
• Initial Date FDA Received: 12/08/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/17/2017; 02/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1