MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D134805

Device Problems Display or Visual Feedback Problem (1184); Failure to Sense (1559); Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/13/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter for which biosense webster¿s product analysis lab (pal) identified a hole on the surface of the pebax.Initially it was reported that there was discomfort in the behavior of thermocool® smart touch® sf bi-directional navigation catheter during the ablation.It became as if it was trembling.After that, errors 319 and 401 appeared and disappeared.Since there was no significant impact on the procedure, there was no problem in the ablation and the procedure was at the end phase, the thermocool® smart touch® sf bi-directional navigation catheter was used as it was.The procedure was completed without any problems.After the procedure was completed, it was confirmed that blood contaminated into the catheter tip.Timing was 45 minutes after the start of the procedure.There was no patient consequence reported.Additional information was received on 26-jun-2023.Issue was located at the tip electrode.Blood contaminated into the catheter tip.The system did not present any error messages nor did the physician/user see any product problem.There were no issues related to temperature nor flow on the catheter.No char was observed.Additional information was received on 04-jul-2023.The generator parameters were set to power control mode, temperature cut off: 40 and impedance cut off 250o.The act was maintained above 400.The correct catheter settings were selected on the generator.The pump was switching from low to high flow during the ablation.The duration of the ablation was not greater than 60 seconds.There were no average contact force greater than 25 grams.The irrigation rate was not used outside of those prescribed.The pre-ablation high setting was set to pre: 1 second and post: 1 second.Heparinized normal saline was used.Carto visitag module was not used.Sl sheath was used.No difficulty experienced while maneuvering the catheter or during the withdrawal.The catheter pebax was not physically damaged.The issues reported that ¿it became as if it was trembling¿ and the ¿errors¿ were assessed as non mdr reportable.The most likely consequence was an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death was remote.The issue that the blood contaminated into the catheter tip was assessed as non mdr reportable.Foreign material was found underneath the pebax.However, there is no damage reported to the pebax integrity.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 08-aug-2023 there was reddish material inside the pebax and a hole in its surface was observed.The hole on the surface of the pebax was assessed as mdr reportable.The awareness date for this reportable lab finding was 08-aug-2023.

Manufacturer Narrative

E1.Initial reporter phone: (b)(6).The bwi product analysis lab received the device for evaluation on 24-jul-2023.The device evaluation was completed on 08-aug-2023.The device was returned to biosense webster (bwi) for evaluation.A visual inspection and magnetic sensor functionality test of the returned device were performed in accordance with bwi procedures.Visual analysis revealed reddish material inside the pebax and a hole in its surface.Magnetic sensor functionality test was performed and the device was recognized on the system; however, error 105 was displayed on the screen due to the pebax damage and reddish material inside of it.The root cause of the damage on the pebax could not be conclusively determined.All units are inspected prior to leaving the facility as there are functional tests and inspections at control points based on the process flow diagram (pfd) per its part number to avoid this type of damage from leaving the facility.A manufacturing record evaluation was performed for the finished device 31002356l, and no internal action was found during the review.The issues reported by the customer were confirmed.It should be noted that product failure is multifactorial.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.Manufacturer's reference number: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17685410
• MDR Text Key: 322673572
• Report Number: 2029046-2023-01991
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/05/2023

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 Catalogue Number: D134805
• Device Lot Number: 31002356L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2023
• Initial Date Manufacturer Received: 08/08/2023
• Initial Date FDA Received: 09/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2023
• 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
• Treatment: SL SHEATH; SMARTABLATE GEN. KIT (JAPAN); SMARTABLATE PUMP KIT (JAPAN)