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 Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Visual inspection and electrical test of the returned device were performed following bwi procedures.Visual analysis was performed and the peek housing was found damaged.The peek housing was observed on the microscope and it was found evidence of a hole, stress marks and mechanical damage; internal components are exposed.An electrical test was performed, and no electrical issues were found.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The signal interference noise reported by the customer was not confirmed.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.The peek housing damage could be related to the shipping process after procedure however, this cannot be conclusively determined.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).
Event or Problem Description
It was reported that a patient underwent a supraventricular tachycardia (svt( ablation procedure with a navi-star¿ thermo-cool¿ electrophysiology catheter for which biosense webster¿s product analysis lab (pal) identified a hole on the pebax.It was initially reported by the customer that during the operation, the signal interference noise was observed on ic, bs, or all ecg (bs + ic) channels.A second device was used to complete the operation.There was no adverse event reported on patient.The customer¿s reported signal interference issue is not considered to be mdr reportable since the risk to the patient is low.On 27-jan-2023, the bwi pal revealed that a visual inspection of the returned device found the peek housing was damaged.Microscopic examination found evidence of a hole, stress marks and mechanical damage with internal components are exposed.This finding was reviewed and assessed as an mdr reportable malfunction since the integrity of the device had been compromised.

• 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: 16425341
• Report Number: 2029046-2023-00341
• Device Sequence Number: 5659937
• 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): 02/22/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/10/2025
• Device Model Number: NI75TCFH
• Device Catalogue Number: NI75TCFH
• Device Lot Number: 30845964M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2023
• Initial Report FDA Received Date: 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2022
• 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: DEF 7.5F,TCNSTC,4P,F,252MM,HYP
• Patient Sex: Unknown