MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D134702

Device Problem Communication or Transmission Problem (2896)

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

Event Date 01/27/2023

Event Type  malfunction  

Event Description

It was reported a patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with two (2) thermocool® smart touch® sf uni-directional navigation catheters that experienced noise on all ecg signals.It was reported by the caller, the bwi representative, that there was noise on all ecg signals, both bs + ic on both the carto 3 system and the recording system.The cable was replaced without resolution.The catheter was replaced and the issue was still there.The cable was again replaced but the issue continued to be there.The catheter was replaced once again and the issue was resolved and the case continued.It was reported the physician did not have any intact ecg signal to monitor the patients heart rhythm.The issue occurred while in the body when these ablation catheters were connected.There was no patient consequence reported.

Manufacturer Narrative

On 20-feb-2023.He bwi product analysis lab received the complaint device for evaluation.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster manufacturer's reference number (b)(4) has two reports: mfr # 2029046-2023-00366 for product code d134702 (thermocool® smart touch® sf uni-directional navigation catheter).Mfr # 2029046-2023-00367 for product code d134702 (thermocool® smart touch® sf uni-directional navigation catheter).

Manufacturer Narrative

It was reported a patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with two (2) thermocool® smart touch® sf uni-directional navigation catheters that experienced noise on all ecg signals.It was reported by the caller, the bwi representative, that there was noise on all ecg signals, both bs + ic on both the carto 3 system and the recording system.The cable was replaced without resolution.The catheter was replaced and the issue was still there.The cable was again replaced but the issue continued to be there.The catheter was replaced once again and the issue was resolved and the case continued.It was reported the physician did not have any intact ecg signal to monitor the patients heart rhythm.The issue occurred while in the body when these ablation catheters were connected.There was no patient consequence reported.Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.The returned device's visual inspection and electrical tests were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.An electrical test was performed, and no electrical issues were found.The electrical issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.The instructions for use contain the following recommendation: ecg noise is typically generated as the result of the improper connection of the body surface ecg patch to the patient.This noise is the most significant during ablation.To resolve this situation, verify the proper connection.It is recommended to turn off the notch filter for this verification.A manufacturing record evaluation was performed for the finished device, and no internal actions related to the complaint were found during the review.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 ref.# (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION 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: 16433678
• MDR Text Key: 310366570
• Report Number: 2029046-2023-00367
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009781
• UDI-Public: 10846835009781
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/31/2023

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: 11/04/2022
• Device Model Number: D134702
• Device Catalogue Number: D134702
• Device Lot Number: 30945031L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/27/2023
• Initial Date FDA Received: 02/23/2023
• Supplement Dates Manufacturer Received: 03/09/2023
• Supplement Dates FDA Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2022
• 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
• Treatment: THMCL SMTCH SF UNID, TC, F; THMCL SMTCH SF UNID, TC, F; UNKNOWN CATHETER CABLE; UNKNOWN CATHETER CABLE