MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING

Catalog Number	NS7TCFL174HS
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	08/03/2018
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) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.Manufacturer ref no: (b)(4).
Event or Problem Description
It was reported that a patient underwent an ablation procedure for idiopathic ventricular tachycardia (idvt) with a navistar¿ electrophysiology catheter and suffered a transient atrioventricular heart block requiring a pacemaker implantation.During ablation phase, a transient occurred.No immediate intervention was performed.The patient recovered.Remainder of the procedure was aborted.On post-procedure day 1, although the atrioventricular (av) block was recovered, a pacemaker was implanted as it might have become a second-degree av-block (2:1).There¿s no information regarding extended hospitalization or patient¿s outcome.The physician did not attribute the adverse event to a bwi product malfunction.Multiple attempts have been made to gain clarification on this event with no response.Should any new information be obtained it will be assessed and processed accordingly.
Additional Manufacturer Narrative
It was reported that a male patient underwent an ablation procedure for idiopathic ventricular tachycardia (idvt) with a navistar¿ electrophysiology catheter and suffered a transient atrioventricular heart block requiring a pacemaker implantation.During ablation phase, a transient atrial ventricular heart block occurred.The patient recovered.The remainder of the procedure was aborted.There is no information regarding extended hospitalization.Patient¿s outcome is improved.Physician¿s opinion regarding the cause of the adverse event is that it was procedure-related.Manufacturer ref no:(b)(4).

• Brand Name: NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7833975
• Report Number: 2029046-2018-02006
• Device Sequence Number: 2488773
• Product Code: DRF
• UDI-Device Identifier: 10846835000610
• UDI-Public: 10846835000610
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P990025
• 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
• Report Date (Section B): 10/01/2018

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: 02/27/2019
• Device Catalogue Number: NS7TCFL174HS
• Device Lot Number: 17444106M
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/10/2018
• Supplement Date Received by Manufacturer: 10/01/2018
• Initial Report FDA Received Date: 08/30/2018
• Supplement Report FDA Received Date: 10/29/2018
• 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: Required Intervention