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

Catalog Number D134805

Device Problems Communication or Transmission Problem (2896); Electrical Shorting (2926)

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

Event Date 01/26/2024

Event Type  malfunction  

Manufacturer Narrative

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 cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the electrocardiogram (ekg) signals went out.It was reported that their ekg signals went out, an error 19, sim card error appeared and then a current leakage error 7 displayed on the carto 3 system.The cable was replaced three times without resolution.The catheter was replaced without resolution.When the cable was replaced again, the issues resolved, and the case continued.No adverse patient consequence was reported.Additional information was received.The "current leakage error" was accompanied by a signal noise.The signals were very noisy along with this.That happened before the ekg ¿got messed up¿.The intracardiac (ic) signals ¿already messed up before, but became even worse after¿.The signal interference (noise/loss) were observed on both the carto and recording system.There was no other ecg/ekg signal available for the physician to monitor the patient¿s heart rhythm.They were only using the carto to monitor in that instance.The catheter was inside the patient¿s body at the time of signal interference/loss.Additional clarification was requested to see if there was signal interference on carto, or was it used to monitor the patient¿s heart rhythm.The response was: ¿not sure.We might¿ve had another system in use too since there was a device before¿.

Manufacturer Narrative

It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the electrocardiogram (ekg) signals went out.It was reported that their ekg signals went out, an error 19, sim card error appeared and then a current leakage error 7 displayed on the carto 3 system.The cable was replaced three times without resolution.The catheter was replaced without resolution.When the cable was replaced again, the issues resolved, and the case continued.No adverse patient consequence was reported.Additional information was received.The "current leakage error" was accompanied by a signal noise.The signals were very noisy along with this.That happened before the ekg ¿got messed up¿.The intracardiac (ic) signals ¿already messed up before, but became even worse after¿.The signal interference (noise/loss) were observed on both the carto and recording system.There was no other ecg/ekg signal available for the physician to monitor the patient¿s heart rhythm.They were only using the carto to monitor in that instance.The catheter was inside the patient¿s body at the time of signal interference/loss.Additional clarification was requested to see if there was signal interference on carto, or was it used to monitor the patient¿s heart rhythm.The response was: ¿not sure.We might¿ve had another system in use too since there was a device before¿.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual inspection, magnetic sensor functionality, and electrical tests of the returned device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.A magnetic sensor functionality test was performed, and the device was visualized and recognized correctly.No current leakage issues were observed; however, error 106 was displayed due to an open circuit in the tip area.An electrical test was performed, and no electrical issues were found.The force issue is unrelated to the event described by the customer.A manufacturing record evaluation was performed for the finished device number lot 31200794l and no internal action related to the complaint was found during the review.Additionally, the manufacture and expiration dates have been provided.Therefore, fields d4.Expiration date and h4.Device manufacture date have been populated.The electrical and magnetic issues 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.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) / were selected as related to the customer¿s reported ekg signals went out.Investigation findings: open circuit (c0205) / investigation conclusions: cause not established (d15) / component code: sensor (g03012) were selected as related to the force sensor issue that was found during the device investigation.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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18749369
• MDR Text Key: 335887059
• Report Number: 2029046-2024-00565
• Device Sequence Number: 1
• Product Code: LPB
• 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: 03/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D134805
• Device Lot Number: 31200794L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2023
• 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: UNK BRAND CABLE; UNK BRAND CABLE; UNK BRAND CABLE; UNK BRAND CATHETER; UNK_CARTO 3