MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D133604IL

Device Problems Break (1069); Insufficient Cooling (1130); Contamination /Decontamination Problem (2895)

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

Event Date 06/05/2023

Event Type  malfunction  

Manufacturer Narrative

The product investigation was completed (both the photo analysis and the returned physical product).Device evaluation details: according to the picture provided by the customer, biological material was observed on the tip and the pebax of the catheter; however no external damages were observed on the device.However the photo does not provided sufficient information related to the temperature issue reported by the customer, and therefore no results can be obtained from it.The product was returned to biosense webster for evaluation.Bwi conducted a visual inspection and functionality test of the returned device.Visual analysis revealed the pebax component was observed broken with reddish material inside it.The root cause of the broken pebax cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specifications and procedures.Foreign material was observed underneath the electrode which reason for the fourier transform infrared spectroscopy (ft-ir) analysis, the test was ordered to confirm or rule out the type of material observed, and the results concluded that the foreign material found over the thermo cool smart touch catheter surface is primarily composed of polyethylene (pe) material.The cause for the presence of this material in the device remains unknown.Temperature and impedance and cool flow tests were performed and the device was found working correctly.No temperature, impedance, or irrigation issues were observed.The reddish material inside the pebax may be related to the issue described by the customer.The customer complaint was confirmed.It should be noted that product failure is multifactorial.A manufacturing record evaluation was performed for the finished device batch number 31001788m, and no internal actions were identified.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a atrial fibrillation (afib) paroxysmal ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and post procedure the bwi product analysis lab identified a broken pebax.During the procedure, there was a high temperature reading from the catheter when rf (radiofrequency) was being delivered.A second device was used to complete the operation.There was no adverse event reported on patient.The temperature issue is not mdr-reportable.The broken pebax is mdr-reportable.

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY 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: 17775092
• MDR Text Key: 323749979
• Report Number: 2029046-2023-02122
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/19/2023

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 Expiration Date: 03/06/2024
• Device Catalogue Number: D133604IL
• Device Lot Number: 31001788M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2023
• Initial Date Manufacturer Received: 08/23/2023
• Initial Date FDA Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2023
• 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