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

Model Number D133601

Device Problem Expiration Date Error (2528)

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

Event Date 04/14/2023

Event Type  malfunction  

Manufacturer Narrative

The product has not returned for analysis, however, a picture(s) were provided by the customer.Evaluation is still in progress.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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a procedure with a thermocool® smart touch¿ electrophysiology catheter.The catheter was faulty due to a malfunction of the contact force sensor (error 106).The catheter did not zero out, but after several attempts it began to display the hi strength.Photo¿s attached for this issue to include a photo of the label.There were no casualties.Additional information was received.The device has been used after the expiration date.It was confirmed that the expired catheter was used on the patient.The device was received at the facility prior to the expiration date.The product expired during storage.The event was assessed as mdr reportable as expired product was used on the patient.

Manufacturer Narrative

In the 3500a initial, it was reported under h10.Additional manufacturer narrative that the product has not returned for analysis, the h3.Device evaluated by manufacturer? was processed as ¿no¿ and h3.Reason for non- evaluation was processed as "other".Additional information was received on 22-may-2023 stating that the device was not available to return.Therefore, processing h3.Reason for non- evaluation¿ as ¿not returned to manufacturer¿.Additional information received indicates that the device is not available for return; however, the evaluation on the pictures provided by the customer are still in progress.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.Added in h6.Type of investigation "device not returned".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

It was reported that a patient underwent a procedure with a thermocool® smart touch¿ electrophysiology catheter.The catheter was faulty due to a malfunction of the contact force sensor (error 106).The catheter did not zero out, but after several attempts it began to display the hi strength.Photo¿s attached for this issue to include a photo of the label.There were no casualties.Additional information was received.The device has been used after the expiration date.It was confirmed that the expired catheter was used on the patient.The device was received at the facility prior to the expiration date.The product expired during storage.The picture investigation was completed on 28-jun-2023.A picture was received for evaluation following biosense webster's procedures.According to pictures provided by the customer, alert 106, "force catheter sensor error," and hi (high force value) was observed on carto 3 screen.Regarding the issue related to the device being used after the expiration date, further clarification was received, stating that the device expired in the storage of the customer, so it was properly dispatched.The expired product issue was not confirmed.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint condition were identified.The force issue reported by the customer was confirmed.However, the expired product issue was not confirmed.The device has not been returned for analysis, and a root cause cannot be assigned based on the current evidence.If the device is received in the future, the product investigation will be done and updated accordingly, and any action will be taken if necessary.Investigation findings code of ¿appropriate term/code not available¿ represents photo/video analysis.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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16922918
• MDR Text Key: 315132445
• Report Number: 2029046-2023-01019
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835008982
• UDI-Public: 10846835008982
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: P030031/S053
• 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,Followup,Followup
• Report Date: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2023
• Device Model Number: D133601
• Device Catalogue Number: D133601
• Device Lot Number: 30756605M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2022
• 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