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

Model Number D133601

Device Problems Erratic or Intermittent Display (1182); Failure to Sense (1559); Contamination /Decontamination Problem (2895)

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

Event Date 01/01/2022

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's reference number: (b)(4).

Event Description

It was reported that an unknown patient underwent a persistent atrial fibrillation (afib) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and a foreign material on usable length of the catheter was observed.It was reported that the catheter tip did not seem to be completely clean.The catheter was used as normal, around 100 applications performed with no issue.Suddenly, while ablating, the catheter ¿starts to dance through screen¿.High metal values in mapping port were observed, and when ablation stopped, they returned to normal.For the next ablation, same issue occurred and so the cable was replaced and the issue did not resolve.A new catheter was used to resolve the issue.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.The magnetic sensor and icon jumping issues were assessed as not mdr reportable.The foreign material on usable length of the catheter was assessed as a mdr reportable product malfunction.

Manufacturer Narrative

Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A device history record evaluation was performed for the finished device 30685957m number, and no internal action related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

The device evaluation was completed on 26-aug-2022.It was reported that an unknown patient underwent a persistent atrial fibrillation (afib) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and a foreign material on usable length of the catheter was observed.Device evaluation details: the product was returned to biosense webster for evaluation.Visual inspection, c3 system testing, and sem (scanning electron microscope) were performed on the returned device.Visual analysis of the returned catheter revealed reddish-brown material inside of the pebax.The device was tested for functionality with a carto 3 piu system, and there were no errors or visualization issues with the device and the catheter passed the test.Sem conclusion indicates evidence of mechanical damage and a hole on the pebax surface.As part of bwi¿s quality process, all devices are manufactured, inspected, and released to approved specifications.The events described as magnetic sensor error and icon jumping issues were unable to be duplicated during the product investigation; however, the blood inside the pebax area found could be related to the reported issues.A manufacturing record evaluation was performed for the finished device 30685957m number, and no internal actions related to the complaint were found during the review.The instructions for use contain the following recommendations: the magnetic sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.Improperly positioned patches may increase the chances of a virtual magnetic reference move which is unrelated to patient movement.This could also result in inaccurate catheter visualization.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On 12-jul-2022, the biosense webster, inc.Product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 6465917981
• MDR Report Key: 14102459
• MDR Text Key: 289754148
• Report Number: 2029046-2022-00788
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835008982
• UDI-Public: 10846835008982
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/20/2022

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: 12/26/2022
• Device Model Number: D133601
• Device Catalogue Number: D133601
• Device Lot Number: 30685957M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/15/2022
• Initial Date FDA Received: 04/13/2022
• Supplement Dates Manufacturer Received: 05/12/2022; 07/12/2022; 08/26/2022
• Supplement Dates FDA Received: 06/07/2022; 08/04/2022; 09/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/27/2021
• 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: UNK BRAND CABLE.; UNK BRAND CATHETER.