MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D-1348-05-S

Device Problems Crack (1135); Device Displays Incorrect Message (2591); Device Contamination with Chemical or Other Material (2944); Material Protrusion/Extrusion (2979); Temperature Problem (3022)

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

Event Date 07/10/2017

Event Type  malfunction  

Manufacturer Narrative

Event description continuation: the awareness date for this complaint has been reset to 8/16/2017, the date of the reportable finding.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 an ablation procedure for atrial fibrillation with a thermocool smart touch bidirectional sf catheter where the catheter failed to display temperature values.During the procedure, after the catheter was connected, a temperature sensor error displayed, and no ablation could be conducted.A cable change did not resolve the issue, so the catheter was exchanged.The case then continued without patient consequence.If the catheter fails to display temperature values, ablation cannot be performed, and the catheter must be replaced.The potential that catheters with this issue could cause or contribute to an adverse event is remote.As a result, this is not an mdr reportable event.On 8/16/2017, the biosense webster failure analysis lab received the device for evaluation, and it was found that the peek housing/tip lumen transition was cracked with reddish brown material inside.Additionally, the braid wire was exposed.Additionally, white bumps were noted approximately 2.1cm from the distal end of the tip dome.No metal was exposed in this area.It is unknown if the catheter was withdrawn with any difficulty.The damage was not noted prior to use, upon withdrawal, or before returning the catheter for analysis.It is unknown what kind of sheath was in use.The presence of reddish brown material inside the catheter is an expected finding after a procedure of this type, and is not mdr reportable.The white bumps found near the distal end of the tip dome are also not reportable, as the catheter integrity was maintained in this area.Since there was no evidence that the catheter integrity had been compromised, the potential that this could cause or contribute to an adverse event is remote.However, the crack in the transition near the peek housing/tip lumen is reportable, as exposure to the internal catheter components creates a critical risk of thrombus formation.

Manufacturer Narrative

Manufacturer's reference number: (b)(4).It was reported that a patient underwent an ablation procedure for atrial fibrillation with a thermocool smart touch bidirectional sf catheter where the catheter failed to display temperature values.On 8/16/2017, the biosense webster failure analysis lab received the device for evaluation, and it was found that the peek housing/tip lumen transition was cracked with reddish brown material inside.Additionally, the braid wire was exposed.Additionally, white bumps were noted approximately 2.1cm from the distal end of the tip dome.No metal was exposed in this area.The returned device was visually inspected, and a crack was found with bumps in the peek housing transition and tip lumen.These issues are the result of the t-bar sliding down.The catheter was evaluated for electrical resistance, and the thermocouple test failed.Further examination revealed that the thermocouple wires were broken at the tip section, creating an intermittence of temperature.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 has been verified.The thermocouple failure is detectable in production, preventing devices with this failure from reaching the customer.However, in spite of the controls in place during the manufacturing of a device, inadvertent polyurethane wicking on the thermocouple wires can cause these wires to break in the field or during a procedure because of catheter fatigue.This is an inherent limitation of the design.This failure does not represent any patient safety impact.The root cause of the catheter t-bar displacement cannot be determined, since there was evidence of proper assembly during manufacturing.

• Brand Name: THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: 6813856
• MDR Text Key: 84003147
• Report Number: 9673241-2017-00670
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: (01)10846835010183(11)170306(17)180228(10)17646232L
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 07/10/2017

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: 02/28/2018
• Device Model Number: D-1348-05-S
• Device Catalogue Number: D134805
• Device Lot Number: 17646232L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/10/2017
• Initial Date FDA Received: 08/23/2017
• Supplement Dates Manufacturer Received: 07/10/2017
• Supplement Dates FDA Received: 09/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2017
• 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