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

Model Number	NI75TCFH
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation was completed on 28-jul-2022.A picture showing the tip of the catheter was received for analysis.An analysis was performed.The photo does not provide sufficient information related to the reported event and therefore, no result can be obtained from it.A manufacturing record evaluation was performed for the finished device 30691591m number, and no internal actions related to the reported complaint condition were identified.The customer complaint cannot be confirmed.The product analysis was performed as appropriate in order to find the root cause of the complaint.The device was returned to biosense webster (bwi) for evaluation.A visual inspection and functional test of the returned device were performed following bwi procedures.Visual analysis revealed no anomalies on the device, no sharp rings or damage rings were observed.A dimensional test was performed, and outer diameters of the device were found within specifications.The 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 its performance.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a navi-star¿ thermo-cool¿ electrophysiology catheter and an electrode was damaged without foreign material with sharp/rough edges.During the procedure, the catheter could not advance in the sheath due to the impediment.Another vizigo sheath was used to complete the procedure.There was no report on adverse event on patient.The event was assessed as a not mdr reportable for a ¿resistance with sheath¿ issue.Interference or friction between devices is a known occurrence.If resistance is encountered, the system may be withdrawn as a unit.This is a common practice during procedures.Since the vast majority of ep procedures utilize multiple device exchanges, an increased potential for patient injury was remote.Additional information was received on 05-jul-2022.The middle of the second and third electrode of the catheter was uneven and scratched, making the third and fourth electrodes stuck and being unable to advance in the sheath.It was clarified that no vizigo sheath was used during the procedure.Another catheter was used to complete the surgery, not sheath.They were inserting the catheter into the sheath.The physical damage was a scratch.Additional information was received on 14-jul-2022.The catheter was scratched.The damage did not result in wires being exposed and it was unknown if the damage resulted in any lifted or sharp rings.The third and four electrodes could not enter the sheath, it was stuck.It was not known if the catheter was pre-shaped and the sheath brand, model and french size was unknown.The electrode issue provided on 05-jul-2022 was assessed as mdr reportable for an ¿electrode damaged without foreign material with sharp/rough edges".The awareness date for this reportable issue is 05-jul-2022.

• 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 ; MX
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-7981
• MDR Report Key: 15127368
• Report Number: 2029046-2022-01744
• Device Sequence Number: 15104032
• Product Code: OAD
• UDI-Device Identifier: 10846835000566
• UDI-Public: 10846835000566
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/28/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/10/2024
• Device Model Number: NI75TCFH
• Device Catalogue Number: NI75TCFH
• Device Lot Number: 30691591M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2022
• Initial Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2021
• 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: UNKNOWN BRAND CATHETER; UNKNOWN BRAND SHEATH
• Patient Sex: Unknown