MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVISTAR THERMOCOOL; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Catalog Number	NI75TCDH
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 a supraventricular tachycardia (svt) cardiac ablation procedure.With a navistar thermocool and midway through ablation.The thermocouple holes of the catheter were stuck and the ablation could not be irrigated.Multiple attempts to flush the catheter was performed and failed to unclog the thermocouple holes.They replaced the catheter with a new one.And the case continued without any patient consequences.
Additional Manufacturer Narrative
The biosense webster, inc.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.Correction to the initial report: corrected udi has been populated to field d4.Primary udi number.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
It was reported that a patient underwent a supraventricular tachycardia (svt) cardiac ablation procedure with a navistar thermocool and midway through ablation, the thermocouple holes of the catheter were stuck, and the ablation could not be irrigated.Multiple attempts to flush the catheter was performed and failed to unclog the thermocouple holes.They replaced the catheter with a new one and the case continued without any patient consequences.Device evaluation details: the device was returned to johnson & johnson medtech (j&j) for evaluation.A visual inspection evaluation and irrigation test of the returned device were performed following j&j medtech procedures.Visual analysis of the returned sample revealed no damage or anomalies in the device.An irrigation test was performed, and the device was partially occluded.Further investigation revealed a white foreign material occluding one of the irrigation holes in the dome section.For this reason, a scanning electron microscopy (sem) analysis was requested and it was determined that the foreign material was related to an inorganic salt per the element observed.A manufacturing record evaluation was performed for the finished device 30952941m number, and no internal actions related to the reported complaint condition were identified.Since salt material was found occluding, this failure could be related to the irrigation issue reported by the customer; therefore, the customer complaint was confirmed.The potential cause of the occlusion could be related to the purge prior to the insertion of the device; however, this cannot be conclusively determined.The catheter instructions for use (ifu) contain the following recommendations: purge the catheter and the irrigation tubing with heparinized normal saline prior to insertion of the catheter into the patient.As part of the johnson & johnson medtech 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: NAVISTAR THERMOCOOL
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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: 20028681
• Report Number: 2029046-2024-02734
• Device Sequence Number: 12631593
• Product Code: OAD
• UDI-Device Identifier: 10846835000559
• UDI-Public: (01)10846835000559(17)251113(10)30952941M
• Combination Product (Y/N): N
• Initial Reporter Country: MC
• PMA/510(K) Number: P030031
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/22/2024

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 Expiration Date: 11/13/2025
• Device Catalogue Number: NI75TCDH
• Device Lot Number: 30952941M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2024
• Supplement Date Received by Manufacturer: 08/21/2024; 09/26/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 09/13/2024; 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2022
• 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: NGEN GENERATOR; UNK_NGEN PUMP
• Patient Sex: Unknown