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

Device investigation details: according to the video provided by the customer, the noise and impedance issues were observed on the c3 system.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.The customer complaint was confirmed based on the video received.However, the device has not been returned for evaluation.Since no device has been received, no product investigation can be performed.If the device is received in the future, the product analysis will be performed as appropriate in order to find the root cause of the complaint.Initial reporter phone: (b)(6).Investigation findings code of appropriate term/code not available (c22) is used to represent photo/video analysis.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 three (3) reports: (1) mfr # 2029046-2022-00914 for product code d134805 (thermocool® smart touch® sf bi-directional navigation catheter).(2) mfr # 2029046-2022-00915 for product code d134805 (thermocool® smart touch® sf bi-directional navigation catheter).(3) mfr # 2029046-2022-00916 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 5-apr-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 5-apr-2022 when information was received confirming there was no signal available to monitor patient's cardiac rhythm.

Manufacturer Narrative

On (b)(6) 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).

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.A visual inspection, generator and electrical test of the returned device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.A temperature and electrical tests were performed but, no temperature was displayed due to an open circuit on the tip area, only the impedance was visualized.The impedance 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 it¿s performance.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.To minimize any impedance issues, the following guidelines should be followed.Apparent low power output, high impedance reading, or failure of the equipment to function correctly at normal settings may indicate faulty application of the indifferent electrode(s) or failure of an electrical lead.Do not increase power before checking for obvious defects or misapplication of the indifferent electrode or other electrical leads.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 reported loss of electrical signals.Investigation findings: open circuit (c0205) / investigation conclusions: cause not established (d15) / component code: electrical lead/wire (g02015) were selected for the unrelated issue of no temperature was displayed due to an open circuit.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: 14250355
• MDR Text Key: 295813222
• Report Number: 2029046-2022-00914
• 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: 06/29/2022

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; 06/02/2022
• Supplement Dates FDA Received: 05/22/2022; 06/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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.