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

Model Number D134805

Device Problems Failure to Sense (1559); Communication or Transmission Problem (2896); Electrical Shorting (2926); Temperature Problem (3022)

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

Event Date 12/09/2022

Event Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation.The 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.Manufacturer's reference number: (b)(4).

Event Description

It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.It was reported that the smartablate generator displayed a very erratic temperature reading, for the smarttouch sf catheter.The medical team reported that after the smarttouch sf catheter was inserted into the body, the carto 3 system displayed a current leakage alert, error 105, map: catheter sensor error, and all ecg and intracardiac signals were lost on the carto 3 and recording system.The cable was replaced without resolution.The smarttouch sf catheter was replaced and the issue resolved.The procedure continued.No patient consequences were reported.Current leakage is not mdr-reportable.No temperature is not mdr-reportable.Magnetic sensor error is not mdr-reportable.Bad/no ecg on all channels (bs and ic) is mdr-reportable.

Manufacturer Narrative

On 7-feb-2023, the product investigation was completed.It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.It was reported that the smartablate generator displayed a very erratic temperature reading, for the smarttouch sf catheter.The medical team reported that after the smarttouch sf catheter was inserted into the body, the carto 3 system displayed a current leakage alert, error 105, map: catheter sensor error, and all ecg and intracardiac signals were lost on the carto 3 and recording system.The cable was replaced without resolution.The smarttouch sf catheter was replaced and the issue resolved.The procedure continued.No patient consequences were reported.Device evaluation details: visual analysis revealed corrosion in the connector of the device.All the previously mentioned tests were performed, and no issues were observed.A manufacturing record evaluation was performed for the finished device, and no non-conformances related to the reported complaint condition were identified.As an additional test the device was opened and dissected, no corrosion was observed.The issues reported by the customer could be related to the corrosion found in the connector; the instructions for use contain the following recommendation: the current leakage disconnect the body surface ecg cable and all catheter extension cables from the patient interface unit (piu).If the problem persists, replace the catheter cable or the catheter.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: 16092796
• MDR Text Key: 306653775
• Report Number: 2029046-2023-00016
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/03/2023

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 Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30917140L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/09/2022
• Initial Date FDA Received: 01/04/2023
• Supplement Dates Manufacturer Received: 02/07/2023
• Supplement Dates FDA Received: 03/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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