MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVI-STAR RMT ELECTROPHYSIOLOGY CATHETER; ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION

Model Number	NR7TCS4YU
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	01/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old male patient ((b)(6) lbs) underwent an atrial fibrillation (afib) ablation procedure with a navi-star¿ rmt electrophysiology catheter on (b)(6) 2021 and suffered cerebrovascular accident (cva) requiring prolonged hospitalization.No bwi product malfunctions nor immediate patient consequences from the ablation procedure were reported.Max wattage used was 35 watts.On (b)(6) 2021, the clinical account specialist (cas) that supported the case, was made aware that post-procedure, the patient developed visual anomalies (loss of right visual field) and cva was confirmed.The patient was admitted in the intensive care unit (icu) and required prolonged hospitalization.There¿s no information regarding medical/surgical interventions.Physician causality opinion is unknown.The patient is currently in some form of outpatient rehabilitation for his visual changes.No further information is available.Since this event is life threatening and required prolonged hospitalization to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.

• Brand Name: NAVI-STAR RMT ELECTROPHYSIOLOGY CATHETER
• Common Device Name: ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 11317823
• Report Number: 2029046-2021-00164
• Device Sequence Number: 4162902
• Product Code: LPB
• UDI-Device Identifier: 10846835008470
• UDI-Public: 10846835008470
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P990025/S9
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: NR7TCS4YU
• Device Catalogue Number: NR7TCS4YU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2021
• Initial Report FDA Received Date: 02/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening
• Patient Age: 62 YR