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	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: the returned device was visually inspected, and it was found peek housing cracked with internals parts exposed.Per the event, the catheter was tested for electrical performance and stockert compatibility and it was found within specifications.A manufacturing record evaluation was performed for the finished device 30259397m number, and no internal action was found during the review.The customer complaint cannot be confirmed.The root cause of the peek housing damage cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specification and procedures.It could be related to the handling of the device during the shipment; however, this cannot be conclusively determined.Additionally, the customer provided a photo of the stockert screen.An evaluation was performed, and according to pictures provided, no impedance was observed.Manufacturer's reference #: (b)(4).
Event or Problem Description
It was reported that a supraventricular tachycardia (svt) ablation procedure with a navi-star¿ thermo-cool¿ electrophysiology catheter for which the biosense webster, inc.Product analysis lab identified a crack in the peek housing with internal wires exposed.Initially it was reported that during the procedure, impedance could not be displayed.A second catheter was used to complete the procedure.No patient consequence was reported.The no impedance issue was assessed as a not reportable issue, since the impedance is not displayed, the device can¿t be used.The potential risk that it could cause or contribute to a death or serious deterioration in state of health is remote.On january 22, 2020, the biosense webster, inc.Product analysis lab received the device for evaluation, and upon initial visual inspection it was noted that the product revealed no physical damage.On february 5, 2020, after further analysis and testing, it was found that the peek housing was cracked with internals parts exposed.This event was originally considered not mdr reportable, however, biosense webster, inc.Became aware of a reportable malfunction through second visual analysis on february 5, 2020 and have reassessed this complaint as reportable.Therefore, the awareness date for this reportable lab finding is february 5, 2020.

• 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; 33 technology drive; irvine CA 92618
• MDR Report Key: 9774998
• Report Number: 2029046-2020-00323
• Device Sequence Number: 14056275
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/24/2019

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: 07/15/2022
• Device Model Number: NI75TCFH
• Device Catalogue Number: NI75TCFH
• Device Lot Number: 30259397M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 03/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1