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

Catalog Number	D6DR005RT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	04/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.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.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 products: thermocool smarttouch bidirectional sf catheter (model# d134804s lot# 17772677l).Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a patient underwent an ablation procedure for ventricular tachycardia (vt) with a webster¿ electrophysiology catheter and suffered cardiac arrest requiring defibrillation and cardiopulmonary resuscitation (cpr).Catheters were placed, soundstar catheter was positioned in the right ventricle and soundmap of the left ventricle was completed.Transseptal puncture was then performed.Smarttouch sf was positioned in the left ventricle and pacing maneuvers were performed from the right ventricular apex (rva) quad catheter in an attempt to induce the clinical vt.Multiple runs of vt were induced, of which at least 2 were shockable.Patient was defibrillated and went into pulseless electrical activity (pea) and cpr was successfully performed.Remainder of procedure was aborted.No ablation was performed.Patient was transferred to the intensive care unit (icu) for observation.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.

• Brand Name: WEBSTER¿ ELECTROPHYSIOLOGY CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7463148
• Report Number: 2029046-2018-01481
• Device Sequence Number: 1030809
• Product Code: DRF
• UDI-Device Identifier: 10846835000245
• UDI-Public: 10846835000245
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K892265
• 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): 04/02/2018

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: 01/25/2021
• Device Catalogue Number: D6DR005RT
• Device Lot Number: 30013221M
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/02/2018
• Initial Report FDA Received Date: 04/25/2018
• 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: Life Threatening; Required Intervention