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); Device Sensing Problem (2917)

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

Event Date 01/07/2022

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Initial reporter phone: (b)(6).Biosense webster manufacturer's reference number (b)(4) has three reports: mfr # 2029046-2022-00914 for product code d134805 (thermocool® smart touch® sf bi-directional navigation catheter) and mfr # 2029046-2022-00915 for product code d134805 (thermocool® smart touch® sf bi-directional navigation catheter).

Event Description

It was reported that a patient underwent a cardiac ablation procedure with three (3) thermocool® smart touch® sf bi-directional navigation catheter and there was loss of ecg signal with no intact signal available.When the physician started the ablation the ecg signals disappeared and impedance value started to change.There was no error on carto system.Fluoro tube wasn't too close to the location pad and it was in ap location.The cable was changed with new one but nothing changed.Finally, the catheter was changed to a new one.There was no patient consequences.On (b)(6) 2022, additional information was received indicating the physician did not have any intact ecg signal available to monitor patient heart rhythm.The signal loss was observed on all ecg (bs + ic) channels.The signal loss was observed on both carto® and recording system.During the signal loss issue the affected catheter was inside the patient¿s body.The impedance value was variable.The impedance cut-off value was not exceeded.The defibrillator was open and near the patient but it was not connected to the patient.The event was initially assessed as not mdr reportable until (b)(6) 2022 when information was received confirming there was no signal available to monitor patient's cardiac rhythm.

Manufacturer Narrative

It was reported that a patient underwent a cardiac ablation procedure with three (3) thermocool® smart touch® sf bi-directional navigation catheter and there was loss of ecg signal with no intact signal available.When the physician started the ablation the ecg signals disappeared and impedance value started to change.There was no error on carto system.Fluoro tube wasn't too close to the location pad and it was in ap location.The cable was changed with new one but nothing changed.Finally, the catheter was changed to a new one.There was no patient consequences.Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Visual inspection and temperature and impedance test of the returned device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.A temperature and impedance test was performed and the device was found working correctly.No temperature or impedance issues were observed.An electrical test was performed, and no electrical issues were found.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint condition were identified.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.The instructions for use contain the following recommendations: - when rf current is interrupted for either a temperature or an impedance rise (the set limit is exceeded), the catheter should be removed, and the tip cleaned of coagulum, if present.- 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

On 18-may-2022, the 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.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 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 6465917981
• MDR Report Key: 14250349
• MDR Text Key: 290453292
• Report Number: 2029046-2022-00916
• 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: 06/24/2022

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: 10/12/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30653080L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/05/2022
• Initial Date FDA Received: 04/29/2022
• Supplement Dates Manufacturer Received: 05/18/2022; 05/30/2022
• Supplement Dates FDA Received: 05/22/2022; 06/24/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/13/2021
• 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: CARTO 3 SYSTEM; SMARTABLATE GENERATOR KIT-WW; THMCL SMTCH SF BID, TC, D-F; THMCL SMTCH SF BID, TC, D-F; UNKNOWN CABLE