MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; SIMILAR DEVICE D133601, PMA # P030031/S053

Catalog Number D133604IL

Device Problem Insufficient Cooling (1130)

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

Event Date 05/20/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent a cardiac ablation procedure with an thermocool® smart touch¿ electrophysiology catheter for which biosense webster¿s product analysis lab (pal) identified a broken pebax.It was initially reported that during the operation, there was an issue with the temperature sensor.However, the customer did not provide details.A second device was used to complete the operation.There was no adverse event reported on patient.Additional information received indicated the issue was high temperature, but they could not ablate.The temperature cut off was 55,35w.The customer¿s reported temperature issue is not considered to be mdr reportable since the user-defined cut-off was not exceeded and the potential that it could cause or contribute to a death, serious injury, or other significant adverse event, is remote.On 3-jul-2023, the bwi pal revealed that a microscope analysis of the returned device found that the pebax was broken, exposing internal components.This finding was reviewed and assessed to be an mdr reportable malfunction since the integrity of the device is compromised.

Manufacturer Narrative

Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Visual inspection, temperature, impedance, cool flow pump, pressure gauge and patency tests of the returned device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.The temperature and impedance test was performed, and no temperature was displayed due to an open circuit on the tip area.A cool flow pump and pressure gauge tests were performed, and the device was irrigating out of specifications.Due to the irrigation condition, a microscope analysis revealed that the pebax was broken, exposing internal components.Additionally, a patency test was performed and confirmed a leakage through the pebax.The issue could be contributed to the reported event by the customer.The root cause could be related to the handling since in the process there are control inspection points to avoid these issues.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.The instructions for use contain the following warning stated in the carto 3 system manual: if the radiofrequency (rf) generator does not display temperature, verify that the appropriate cable is plugged into the rf generator.A manufacturing record evaluation was performed for the finished device, and no internal action was found during the review.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: investigation findings: material and/or chemical problem identified (c06) / investigation conclusions: cause not established (d15) / component code: sleeve (g04115) were selected as related to the issue of broken pebax.Investigation findings: open circuit (c0205) / investigation conclusions: cause not established (d15) / component code: electrical lead/wire (g02015) were selected as related to the customer's reported temperature issue.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: SIMILAR DEVICE D133601, PMA # P030031/S053
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (IRWINDALE); 15715 arrow highway; irwindale CA
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17402324
• MDR Text Key: 320600313
• Report Number: 2029046-2023-01606
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: D133604IL
• Device Lot Number: 30985505M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2023
• Date Manufacturer Received: 07/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: THMCL SMARTTOUCH,TC,D,C3,OBL