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	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.The date of event was not provided, as such, field b3.Date of event has been left blank.Manufacturer's ref.# (b)(4).
Event or Problem Description
It was reported that a patient underwent an ablation procedure with a navi-star¿ thermo-cool¿ electrophysiology catheter and the catheter was reported to have internal wires exposed.It was reported that the navi-star¿ thermo-cool¿ electrophysiology catheter was physically broken, the shaft was destroyed, and internal wires were exposed.No sharp/lifted electrodes were observed.The catheter was not pre-shaped.The catheter was not inside the patient when the issue occurred.It was being used with a preface sheath no patient consequences were reported.
Additional Manufacturer Narrative
It was reported that the navi-star¿ thermo-cool¿ electrophysiology catheter was physically broken, the shaft was destroyed, and internal wires were exposed.No sharp/lifted electrodes were observed.The catheter was not pre-shaped.The catheter was not inside the patient when the issue occurred.It was being used with a preface sheath no patient consequences were reported.Device investigation details: the device investigation has been completed which included a manufacturing record evaluation (mre).Manufacturing record evaluation was performed for the finished device 30316930m number, and no non-conformances related to the reported complaint was found during the review.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer¿s ref # (b)(4).
Additional Manufacturer Narrative
It was reported that a patient underwent an ablation procedure with a navi-star¿ thermo-cool¿ electrophysiology catheter and the catheter was reported to have internal wires exposed.It was reported that the navi-star¿ thermo-cool¿ electrophysiology catheter was physically broken, the shaft was destroyed, and internal wires were exposed.No sharp / lifted electrodes were observed.The catheter was not pre-shaped.The catheter was not inside the patient when the issue occurred.It was being used with a preface sheath no patient consequences were reported.Device evaluation details: on 10/20/2020, the bwi product analysis lab received the complaint device for evaluation and the evaluation has been completed.The device was visually inspected and the initial visual analysis observed no connector detached from the handle, wires exposed or damage on the shaft.A manufacturing record evaluation was performed, and no internal action related to the reported complaint was found during the review.The customer complaint was confirmed.The root cause of connector detached from the handle cannot be determined since polyurethane (pu) residues were observed on the connector, this is evidence than the catheter was properly manufactured.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.; 33 technology drive; irvine CA 92618
• MDR Report Key: 10339427
• Report Number: 2029046-2020-00961
• Device Sequence Number: 14211159
• Product Code: OAD
• UDI-Device Identifier: 10846835000566
• UDI-Public: 10846835000566
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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,Followup,Followup
• Report Date (Section B): 06/29/2020

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: 11/10/2020
• Device Model Number: NI75TCFH
• Device Catalogue Number: NI75TCFH
• Device Lot Number: 30316930M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Initial Date Received by Manufacturer: 06/29/2020
• Supplement Date Received by Manufacturer: 06/29/2020; 10/20/2020
• Initial Report FDA Received Date: 07/29/2020
• Supplement Report FDA Received Date: 09/01/2020; 11/17/2020
• 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: UNK_PREFACE SHEATH.