MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number D-1292-05-S

Device Problems Material Discolored (1170); Display or Visual Feedback Problem (1184); Device Displays Incorrect Message (2591)

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

Event Date 09/29/2016

Event Type  malfunction  

Manufacturer Narrative

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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Concomitant medical product: smart touch unidirectional catheter, model #: d-1336-02-s, lot #: 16047057m.(b)(4).

Event Description

It was reported that a patient underwent a procedure with an ez steer thermocool navigational 4mm catheter and it did not show the temperature.They reconnected the cable and then changed to another cable.However, this did not resolve the issue.They then changed the catheter to a smart touch unidirectional catheter.However, there was a magnetic sensor error.Therefore, they changed this catheter again and completed the procedure with no patient consequence.The temperature and magnetic sensor error issues were assessed as not reportable as the potential risk that they could cause or contribute to a death or serious deterioration in state of health was remote.The biosense webster failure analysis lab discovered on (b)(6) 2016, the braid was exposed and the shaft was discolored.The approximate size of the braid exposed was 30cm in length and was about 13 cm from the client tip.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.This returned catheter condition has been assessed as a reportable malfunction as the catheter integrity was not maintained and internal components were exposed to the patient.The awareness date was reset to (b)(6) 2016.

Manufacturer Narrative

Additional information was received on this complaint on january 13, 2017.The temperature of the storage room is around 27ºc.This catheter had been kept in a car for about 2-3 days which and been parked in sunlight more than 4 hours on each day.Also, this returned catheter condition was not noticed.The sheath used was either the slo or sro.There was no difficulty experienced while maneuvering the catheter or during the withdrawal.(b)(4) it was reported that a patient underwent a procedure with an ez steer thermocool navigational 4mm catheter and it did not show the temperature.They reconnected the cable and then changed to another cable.However, this did not resolve the issue.They then changed the catheter to a smart touch unidirectional catheter.However, there was a magnetic sensor error.Therefore, they changed this catheter again and completed the procedure with no patient consequence.The device was visually inspected and the shaft was found discolored and the internal braid was exposed in some areas.Different analytical techniques as fourier transform infra red analysis (ftir) and thermogravimetric analysis (tga) were carried out to determine the root cause of the failure.The results reveal an advanced degradation condition caused by an external source such as light, humidity, temperature and others.Body shaft have an advanced state of degradation directly affecting their thermal performance.During manufacturing all the catheters are inspected for visual damages before packaging.On line inspections are in place to prevent this type of damage/defect from leaving the facility.Per the event, the catheter was tested for electrical performance, temperature response and generator compatibility and it was found within specifications.The device history record (dhr) was reviewed and no anomalies were found.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.The customer complaint regarding temperature issues has not been verified.In other hand, the root cause of the damage found on the shaft could not be determined.However, neither the analysis nor the dhr suggest that the failure reported could not be related to the manufacturing process.Further information provided stated that the catheter was kept in a car for 2-3 days, and during this time it was in sunlight more than 4 hours.As per the instructions for use (ifu) information, the storage instruction showed that the catheter should be stored in a cool, dry, dark place.Storage temperature should be between 5 and 25ºc (41 and 77ºf).

• Brand Name: EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6146816
• MDR Text Key: 61870608
• Report Number: 9673241-2016-00841
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 10846835003338
• UDI-Public: (01)10846835003338(11)140123(17)161231(10)16033224M
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: P030031
• 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
• Report Date: 09/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Model Number: D-1292-05-S
• Device Catalogue Number: BNI75TCDFH
• Device Lot Number: 16033224M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2014
• 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