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

Catalog Number D133604IL

Device Problems Insufficient Cooling (1130); Material Puncture/Hole (1504); Incorrect, Inadequate or Imprecise Result or Readings (1535); Contamination /Decontamination Problem (2895); Material Twisted/Bent (2981)

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

Event Date 10/13/2023

Event Type  malfunction  

Manufacturer Narrative

The product investigation was completed.Device evaluation details: the product was returned to biosense webster for evaluation.Bwi conducted a visual inspection and functional test of the returned device.Visual inspection was performed, and a hole was observed on the pebax surface with reddish material inside.The root cause of the damage on pebax cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specifications and procedures.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 magnetic and force feature was tested and no errors were observed.The force values and the vector were observed within specifications.No force issues were observed, however, the reddish material inside the pebax could be related to the force issue reported by the customer.A manufacturing record evaluation was performed for the finished device batch number 31103263m, and no internal actions were identified.The issue reported by the customer was confirmed.Product failure is multifactorial.The instructions for use (ifu) contain the following recommendations: the force sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.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 an atrial fibrillation cardiac ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and post procedure the bwi product analysis lab identified a hole in the pebax.During the procedure, the tip or splines of the catheter was found bent (with no exposed wires).There was a high temperature reading from the catheter when rf (radiofrequency) was being delivered, and when the temperature cut-off value was exceeded the ablation was automatically stopped as designed.The force values displayed were high.There was no difficulty in removing or maneuvering the device.No pebex damage was noted.A second device was used to complete the operation.There was no adverse event reported on patient.

• 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: 18378262
• MDR Text Key: 331371255
• Report Number: 2029046-2023-03056
• 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: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D133604IL
• Device Lot Number: 31103263M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2023
• Date Manufacturer Received: 11/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2023
• 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: CORDIS 8F SHEATH; SMARTABLATE GENERATOR