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

Catalog Number D134701

Device Problems Device Contamination with Body Fluid (2317); Excessive Heating (4030)

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

Event Date 07/19/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter for which biosense webster¿s product analysis lab (pal) identified a hole in the pebax.Initially it was reported that the handle heated up strongly during ablation.Blood in the catheter tip.Exchanged the catheter to a new one with success.There was no patient consequence reported.Additional information was received.Char was located on the catheter tip electrode.It was unknown if the system presented any error messages or if the physician/user saw any product problem.It was unknown if there were any issues related to temperature and flow on the catheter.The contact force used was unknown.The generator parameters were set to power control mode; temperature cut off was at 40°c.They did not note the temperature, impedance, and power.It was not known if the patient was anticoagulated.It was not known if the patient exhibited any neurological symptoms since the procedure was completed.It was unknown if the physician considered the char excessive or if the physician considered the amount of char observed caused a potential risk to this patient.It was unknown if the correct catheter settings were selected on the generator.It was unknown if the pump was switching from ¿low¿ to ¿high¿ during ablation.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on (b)(6) 2023, they observed reddish material inside the pebax.The device was further observed under magnification and a hole in the pebax was found.No char residues were observed.The event was originally considered non-reportable, however, bwi became aware of the hole in the pebax on (b)(6) 2023 and have assessed this returned condition as reportable.

Manufacturer Narrative

The investigation was completed on (b)(6) 2023.The device was returned to biosense webster (bwi) for evaluation.Bwi conducted a visual inspection, a generator, and irrigation testing of the returned device.Visual analysis revealed reddish material inside the pebax.The device was further observed under magnification and a hole in the pebax was found.No char residues were observed.The device was connected to the generator, and temperature/impedance values were observed within specifications.Then, a cool flow pump test was performed, and no irrigation issues were observed.Also, handle warm testing was performed, and the handle temperature was measured while connected to a carto 3 system and generator.The device passed the specification, as it did not heat up during the test.A manufacturing record evaluation was performed for the finished device number, and no internal actions related to the complaint were found during the review.The reddish material inside the pebax could be related to the blood reported by the customer so the condition can be confirmed.The handle warming issue could not be replicated during the investigation.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.The hole in the pebax found could be related to excessive force or manipulation, but this cannot be conclusively determined.The root cause of the hole remains unknown.As part of bwi¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: -investigation findings: no device problem found (c19)/ investigation conclusions: no problem detected (d14) were selected as related to the customer¿s reported ¿handle heated up¿.-investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: sleeve (g04115) were selected as related to the customer¿s reported ¿char¿ issue and the biosense webster inc.Analysis finding of the ¿reddish material inside the pebax and a hole in the pebax¿.Manufacturer's reference number: pc-(b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF UNI-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: 18176879
• MDR Text Key: 328626140
• Report Number: 2029046-2023-02714
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009774
• UDI-Public: 10846835009774
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Physician
• Type of Report: Initial
• Report Date: 11/20/2023

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: D134701
• Device Lot Number: 30965981L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2023
• Initial Date FDA Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2023
• 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: SMARTABLATE GENERATOR KIT-WW; SMARTABLATE PUMP KIT-WW