MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVISTAR¿ DS ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Catalog Number	NS7TCF8L174HS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arrhythmia (1721); No Code Available (3191)
Date of Event	09/06/2018
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.The device history record (dhr) for the lot number 30057364m has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.Concomitant product: carto® 3: u.S.Catalog #: unknown, serial number: unknown.(b)(4).
Event or Problem Description
It was reported that a (b)(6) male patient underwent an ablation procedure for right sided atrial flutter with a navistar¿ ds electrophysiology catheter and suffered atrioventricular heart block requiring permanent pacemaker implantation.During the procedure, a complete heart block was noticed and was confirmed by carto 3 and electrophysiology recording systems.A permanent pacemaker was implanted.The patient was reported to be in stable condition after the procedure.Extended hospitalization was required as a result of the adverse event.Patient¿s outcome is unchanged.Physician¿s opinion regarding the cause of the adverse event is that it was procedure and patient condition related.

• Brand Name: NAVISTAR¿ DS 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: 7936439
• Report Number: 2029046-2018-02127
• Device Sequence Number: 1499938
• Product Code: OAD
• UDI-Device Identifier: 10846835000603
• UDI-Public: 10846835000603
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P010068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/07/2018

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: 05/14/2021
• Device Catalogue Number: NS7TCF8L174HS
• Device Lot Number: 30057364M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/07/2018
• Initial Report FDA Received Date: 10/04/2018
• 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; Required Intervention