MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) NAVISTAR® THERMOCOOL® ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number D-1197-17-S

Device Problems Bent (1059); Break (1069); Device Inoperable (1663); Material Protrusion/Extrusion (2979)

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

Event Date 06/20/2017

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.(b)(4).

Event Description

It was reported that a patient underwent a procedure with a navistar thermocool catheter where the deflection mechanism stopped working.During the procedure, the catheter lost the ability to deflect properly.The catheter was exchanged for a new one, and the case continued without patient consequence.If a catheter cannot deflect or relax completely, the user must replace the device.The potential that this could cause or contribute to an adverse event is remote.As a result, this is not an mdr reportable event.On 8/14/2017, the biosense webster failure analysis lab received the device for investigation, and it was found that the peek housing was bent and broken with lead wires exposed between the first and second electrodes.No difficulty was noted during the withdrawal of the catheter from the patient¿s body.The damage was not noticed before use, upon withdrawal, or prior to returning the catheter for analysis.It is unknown what kind of sheath was in use.If the internal catheter components are exposed, there is a critical risk of thrombus formation.As a result, this event is mdr reportable.The awareness date for this event has been reset to 8/14/2017, when the reportable findings were discovered.

Manufacturer Narrative

Manufacturer's reference number: (b)(4).It was reported that a patient underwent a procedure with a navistar thermocool catheter where the deflection mechanism stopped working.On 8/14/2017, the biosense webster failure analysis lab received the device for investigation, and it was found that the peek housing was bent and broken with lead wires exposed between the first and second electrodes.The returned device was visually inspected, and the peek housing was found bent and broken with lead wires exposed.Per the reported event, a deflection test was performed, which the catheter passed.Per the observed damage, scanning electron microscope (sem) analysis was performed, and the results showed evidence of a hole and mechanical damage on the surface of the peek housing.It is possible that the damage was caused by contact with an unknown object.No other anomalies were observed.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.During the manufacturing process, all catheters are inspected for visual damage prior to packaging.On-line inspections and functional tests are in place to prevent catheters with this type of damage from leaving the facility.The customer complaint cannot be confirmed.The root cause of the damage on the peek housing cannot be determined, since there is evidence that the catheter was manufactured in accordance with documented specifications and procedures.It is possible that it is related to the handling of the product, but this cannot be conclusively determined.

• Brand Name: NAVISTAR® THERMOCOOL® ELECTROPHYSIOLOGY 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: 6813697
• MDR Text Key: 83685492
• Report Number: 9673241-2017-00669
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 10846835000566
• UDI-Public: (01)10846835000566(11)160909(17)190831(10)17570361M
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 06/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: D-1197-17-S
• Device Catalogue Number: NI75TCFH
• Device Lot Number: 17570361M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2016
• 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