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

Catalog Number	NI75TCFH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	04/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was discarded; therefore, no product failure analysis can be conducted, and device malfunction cannot be confirmed.As such the investigation will be closed.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.A manufacturing record evaluation was performed for the finished device 30152683m number, and no internal actions was found during the review.Biosense webster manufacturer's reference number (b)(4) has two complaints that are related to the same incident.Concomitant products: biosense webster, inc.Product - webster cs catheter with auto id technology, catalog #: d135304, lot #: 30152683m; biosense webster, inc.Product - coolflow tubing set, catalog #: cft003, lot #: cf4383275; biosense webster, inc.Product - carto® 3 system external reference patches, catalog #: crefp6, serial #: (b)(4).Manufacturer's reference # (b)(4).
Event or Problem Description
It was reported that a (b)(6) male patient underwent an atrial fibrillation (afib) procedure with two navi-star¿ thermo-cool¿ electrophysiology catheter and suffered cerebrovascular accident (cva) requiring no interventions but extended hospitalization.The procedure was carried out as usual and had a phase of mapping, ablation and cardioversion.The patient was under general anesthesia.When the patient was awakened from the anesthesia, the physician observed muscular numbness.The patient had developed a cerebral embolism.No medical/surgical intervention was provided; however, extended hospitalization was required as a result of the adverse event.The physician was unsure on whether the adverse event was related to the procedure or patient¿s condition.No biosense webster, inc.Product malfunctions were reported.
Additional Manufacturer Narrative
On april 26, 2019, additional information was received.It was clarified that the date of event was on (b)(6) 2019 and the date a johnson & johnson employee became aware of the event was (b)(6) 2019.Therefore, date of event has been populated with a date of (b)(6) 2019 and date of this report has been populated with a date of april 4, 2019.Manufacturer's reference # (b)(4).
Additional Manufacturer Narrative
During an internal review, it was determined that the manufacturing record evaluation provided in the initial 3500a (b)(4) was incorrect.The information previously reported was: a manufacturing record evaluation was performed for the finished device 30152683m number, and no internal actions was found during the review.However, the correct information is: a manufacturing record evaluation was performed for the finished device 30146786m number, and no internal actions was found during the review.Biosense webster manufacturer's reference number pc-000428538 has two complaints that are related to the same incident.Manufacturer's reference # pc-000428538.

• 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 92618
• MDR Report Key: 8553343
• Report Number: 2029046-2019-03035
• Device Sequence Number: 11335892
• Product Code: OAD
• UDI-Device Identifier: 10846835000566
• UDI-Public: 10846835000566
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P030031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/04/2019

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 Expiration Date: 12/16/2021
• Device Catalogue Number: NI75TCFH
• Device Lot Number: 30146786M
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/01/2019
• Supplement Date Received by Manufacturer: 04/26/2019; 07/11/2019
• Initial Report FDA Received Date: 04/25/2019
• Supplement Report FDA Received Date: 05/16/2019; 07/23/2019
• 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: 64 YR
• Patient Weight: 130