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

Catalog Number	NS7TCBL174HS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); No Code Available (3191)
Date of Event	09/19/2018
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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.The device history record (dhr) for the lot number 30065525m has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.Concomitant bwi products: carto 3 system (us catalog # fg540000, serial # (b)(4)).(b)(4).
Event or Problem Description
It was reported that a male patient underwent an ablation procedure for supraventricular tachycardia (svt) with a navistar¿ electrophysiology catheter and suffered cardiac tamponade requiring surgical intervention.During mapping phase, a cardiac tamponade was confirmed by transthoracic echo (tee).Reminder of the procedure was aborted.The physician had to open patient¿s chest to drain the blood and close the perforation in the heart.The patient was reported to be in stable condition after cardiac surgery.Ablation was not performed, and the patient remains in svt.The patient was transferred to pediatric intensive care unit (picu) and required extended hospitalization.Patient¿s outcome is improved.Patient¿s anatomy was cited as a factor that might have contributed to the adverse event.Physician¿s opinion regarding the cause of the adverse event is that it was procedure-related.There were no error messages displayed on any bwi equipment during the procedure.Transseptal puncture was not performed.The generator was not in use at the time of the injury as no ablation was performed.The patient received anticoagulant (unspecified) during the procedure.The activated clotting time (act) is unknown.

• 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: 7974881
• Report Number: 2029046-2018-02172
• Device Sequence Number: 10813379
• Product Code: DRF
• UDI-Device Identifier: 10846835008531
• UDI-Public: 10846835008531
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 09/19/2018

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: 05/27/2021
• Device Catalogue Number: NS7TCBL174HS
• Device Lot Number: 30065525M
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 10/17/2018
• 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; Life Threatening; Required Intervention