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

Model Number D134805

Device Problems Signal Artifact/Noise (1036); Display or Visual Feedback Problem (1184)

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

Event Date 11/24/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.(b)(4).

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter (stsf)and a signal interference was observed on all channels.It was reported that when the physician gave the radiofrequency (rf) energy, the signals that were observed were noisy and meaningless.The stsf catheter was suddenly moved up and down during the rf ablation time and the pump worked noisily.This situation continued as energy was given.There was no patient consequence.Additional information was received on 14-dec-2021.It was confirmed that the signal interference (noise/loss) was observed on all ecg (bs + ic) channels.The signal interference (noise/loss) was observed on carto and the recording system.No ecg/ekg signal was available for the physician to monitor the patient¿s heart rhythm but these devices were near the piu.During the signal interference/loss, the affected catheter was not inside the patient¿s body.The issue was resolved by replacing it with a new one.

Manufacturer Narrative

It was initially reported that the affected catheter was not inside the patient¿s body.According to the additional information received on 20-dec-2021, the catheter was inside the patient¿s body.The mapping was completed and when the surgeon started the radiofrequency (rf) ablation, the event occurred.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 biosense webster inc.(bwi) product analysis lab received the device for evaluation on 31-jan-2022.The device evaluation was completed on 04-feb-2022.It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter (stsf)and a signal interference was observed on all channels.It was reported that when the physician gave the radiofrequency (rf) energy, the signals that were observed were noisy and meaningless.The stsf catheter was suddenly moved up and down during the rf ablation time and the pump worked noisily.This situation continued as energy was given.There was no patient consequence.Additional information was received and it was confirmed that the signal interference (noise/loss) was observed on all ecg (bs + ic) channels.The signal interference (noise/loss) was observed on carto and the recording system.No ecg/ekg signal was available for the physician to monitor the patient¿s heart rhythm but these devices were near the piu.During the signal interference/loss, the affected catheter was inside the patient¿s body.The mapping was completed and when the surgeon started the radiofrequency (rf) ablation, the event occurred.The issue was resolved by replacing it with a new one.Device evaluation details: a visual inspection, magnetic sensor functionality, and electrical tests of the returned device were performed in accordance with bwi procedures.Visual analysis of the returned thermocool® smart touch® sf bi-directional navigation catheter (stsf) device revealed that no damage was observed on the device.An electrical test was performed, and no electrical issues were found.A magnetic sensor functionality test was performed, and the device was visualized and recognized correctly, no issues were detected.The 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.A manufacturing record evaluation (mre) was performed for the finished device 30579345l number, and no internal actions related to the reported complaint condition were identified.Per the mre, the d.4.Expiration date and h 4.Device manufacture date have been updated.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.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® SF BI-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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13041600
• MDR Text Key: 286512879
• Report Number: 2029046-2021-02226
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P030031
• 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
• Report Date: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30579345L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2021
• 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: UNKNOWN BRAND CATHETER; UNK_CARTO 3