MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SMARTTOUCH; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number	D133601
Medical Device Problem Codes	Insufficient Cooling (1130); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed for the finished device number lot 31360044m and no internal action related to the complaint was found during the review.If the product is received at a later date, the investigation will be updated as applicable.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.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 or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) procedure with a thermocool smarttouch and an irrigation issue occurred during use on the patient.The thermocool smarttouch catheter irrigation connection was obstructed.During the procedure, abruptly after doing ablation of right veins, when the physician tried to ablate, the catheter temperature raised to 50ºc and no ablation could be performed.Changed connector and the same occurred.The physician took the catheter outside of the patient to see if the irrigation holes were obstructed.They saw that the catheter was not irrigating; however, no errors appeared.They realized that the irrigation connection of the catheter was obstructed and no flow could pass.Changed the catheter and the error was solved.No patient consequence.Additional information was received.The temperature cut-off value was reached; however, when it arrived at the cut-off, it stopped the ablation.The generator was set to power control mode, temperature threshold: warning was 43ºc, cut off: 50ºc and impedance cut-off: 250 ohms.The occlusion was not due to foreign material or physical damage.
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation (afib) procedure with a thermocool smarttouch.The thermocool smarttouch catheter irrigation connection was obstructed.During the procedure, abruptly after doing ablation of right veins, when the physician tried to ablate, the catheter temperature raised to 50ºc and no ablation could be performed.Changed connector and the same occurred.The physician took the catheter outside of the patient to see if the irrigation holes were obstructed.They saw that the catheter was not irrigating; however, no errors appeared.They realized that the irrigation connection of the catheter was obstructed and no flow could pass.Changed the catheter and the error was solved.No patient consequence.Additional information was received.The temperature cut-off value was reached; however, when it arrived at the cut-off, it stopped the ablation.The occlusion was not due to foreign material or physical damage.The bwi product analysis lab received the device for evaluation on 12-nov-2024.The device evaluation details: the device was returned to johnson & johnson medtech (j&j) for evaluation.Visual inspection and irrigation test of the returned device were performed following j&j procedures.Visual analysis revealed no damage or anomalies on the device.An irrigation test was performed and the catheter failed the test, the flow in the irrigation hole was very poor.Afterwards, an aluminum wire was introduced in the luer hub, and the wire got stuck at the tip area.Finally, tip was dissected, and the irrigation tube was inspected, and it was found the irrigation tube found folded at the tip section.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The damage on the irrigation tube could be related to the temperature and irrigation issue reported by the customer; therefore, the complaint was confirmed.The potential cause of the issues cannot be conclusively determined.The instructions for use contain the following warning and precautions: purge the catheter and the irrigation tubing with heparinized normal saline prior to insertion of the catheter into the patient.Inspect the irrigation saline for air bubbles prior to its use in the procedure.Air bubbles in the irrigation saline may cause emboli.Always maintain a constant heparinized normal saline infusion to prevent coagulation within the lumen of the catheter.Do not use the catheter without irrigation flow.In relation to the temperature issue, the instruction for use (ifu) contains the following warnings and precautions: before initiating the application of rf energy, a decrease in electrode temperature confirms the onset of saline irrigation of the ablation electrode.Monitoring the temperature from the electrode during the application of rf energy ensures that the irrigation flow rate is being maintained.Monitor the catheter tip temperature throughout the procedure to ensure adequate irrigation.If the temperature increases to 50°c during rf application, power delivery should be interrupted.Recheck the irrigation system prior to restarting the rf application.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.As part of johnson & johnson medtech'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 reference number: (b)(4).

• Brand Name: THERMOCOOL SMARTTOUCH
• Common Device Name: 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: 20511583
• Report Number: 2029046-2024-03443
• Device Sequence Number: 15577636
• Product Code: LPB
• UDI-Device Identifier: 10846835008982
• UDI-Public: (01)10846835008982(17)270624(10)31360044M
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P030031/S053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: D133601
• Device Lot Number: 31360044M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SMARTABLATE GENERATOR KIT-WW; SMARTABLATE PUMP KIT-WW
• Patient Sex: Unknown