MAUDE Adverse Event Report: BIOSENSE WEBSTER INC EZ STEER¿ BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER; ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION

Catalog Number	BD7TCDF4L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arrhythmia (1721); Not Applicable (3189)
Date of Event	02/15/2018
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.Concomitant product: stockert generator (model# 39d76x serial# (b)(4)).Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a male patient underwent an ablation procedure for supraventricular tachycardia (svt) with an ez steer¿ bi-directional electrophysiology catheter and suffered a heart block requiring surgical intervention.During ablation around the slow pathway, the patient went into heart block.A dual-chamber pacemaker was implanted.Patient required extended hospitalization as a result of the adverse event for recovery from pacemaker implantation.Patient outcome remains unchanged.It was noted that the patient arrived at the procedure room in normal sinus rhythm.Physician¿s opinion regarding the cause of the adverse event is that it was procedure-related.There were no issues or errors reported with any bwi products or equipment during the procedure.There were no issues or errors reported with any bwi products or equipment during the procedure.

• Brand Name: EZ STEER¿ BI-DIRECTIONAL 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: 7336681
• Report Number: 2029046-2018-01301
• Device Sequence Number: 161629
• Product Code: LPB
• UDI-Device Identifier: 10846835002515
• UDI-Public: 10846835002515
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P950005/S19
• 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
• Report Date (Section B): 02/15/2018

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: 08/30/2018
• Device Catalogue Number: BD7TCDF4L
• Device Lot Number: 17750642M
• Initial Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 03/13/2018
• 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