MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Catalog Number	NI75TCFH
Medical Device Problem Code	Coagulation in Device or Device Ingredient (1096)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure which included a navi-star¿ thermo-cool¿ electrophysiology catheter and a smartablate¿ irrigation tubing set.It was noted that the ¿tubing kinking results in clots in the ablation catheter¿.The tubing set and the ablation catheter were replaced.Additional information was received.It was reported that there was no char, only clot.There was a pump error, and they noticed a kink on the tube and a lot of clot in the catheter.The patient has not exhibited any neurological symptoms since the procedure was completed.Heparinized normal saline was used as the irrigation fluid.No adverse patient consequence was reported.
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).
Additional Manufacturer Narrative
Correction to the initial report: full udi has been populated to field d4.Primary udi number.It was reported that a patient underwent a cardiac ablation procedure which included a navi-star¿ thermo-cool¿ electrophysiology catheter and a smartablate¿ irrigation tubing set.It was noted that the ¿tubing kinking results in clots in the ablation catheter¿.The tubing set and the ablation catheter were replaced.Additional information was received.It was reported that there was no char, only clot.There was a pump error, and they noticed a kink on the tube and a lot of clot in the catheter.The patient has not exhibited any neurological symptoms since the procedure was completed.Heparinized normal saline was used as the irrigation fluid.No adverse patient consequence was reported.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.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.No thrombus/clot residues were observed.The temperature and impedance test were performed and the device was found working correctly.No temperature or impedance issues were observed.A manufacturing record evaluation was performed for the finished device 31137217m number, and no internal actions related to the reported complaint condition were identified.The clot issue reported by the customer could not be confirmed during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.The catheter instructions for use (ifu) contain the following recommendations: always maintain a constant heparinized normal saline infusion to prevent coagulation within the lumen of the catheter.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).

• Brand Name: NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER
• 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: 19670715
• Report Number: 2029046-2024-02248
• Device Sequence Number: 17871870
• Product Code: OAD
• UDI-Device Identifier: 10846835000566
• UDI-Public: (01)10846835000566(11)230905(17)260904(10)31137217M
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2024

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: 09/04/2026
• Device Catalogue Number: NI75TCFH
• Device Lot Number: 31137217M
• 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: 06/05/2024
• Supplement Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2023
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: G4C-2450; G4CP-2425; SMARTABLATE IRR TUBE SET.
• Patient Sex: Unknown