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 Code	Cardiac Tamponade (2226)
Date of Event	12/13/2019
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 since no lot number was provided, no medical record review (mre) review could be performed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacture reference no: (b)(4).
Event or Problem Description
It was reported that a patient underwent an idiopathic ventricular tachycardia ablation procedure with a navistar¿ electrophysiology catheter and suffered a cardiac tamponade requiring pericardiocentesis.While mapping and ablating in the right ventricular outflow tract with a navistar catheter, a blood pressure drop was noted.Cardiac tamponade was diagnosed on intracardiac ultrasound.A pericardiocentesis was performed, removing 455 ml of fluid.The patient was stable and remained, so ablation was continued.Later in the procedure, error code 40, map: defective catheter or cable, appeared on the carto 3 system when the smart touch sf catheter was connected.The cable was exchanged without resolution.The catheter was exchanged, and the error resolved, case continued successfully.The patient was stable and sent to the coronary care unit after the procedure.The observed error code 40 carto recognition issue has been assessed as not mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.

• 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: 9555884
• Report Number: 2029046-2020-00023
• Device Sequence Number: 14303648
• Product Code: DRF
• UDI-Device Identifier: 10846835000610
• UDI-Public: 10846835000610
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P990025
• 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): 12/13/2019

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 Catalogue Number: NS7TCFL174HS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2019
• Initial Report FDA Received Date: 01/06/2020
• 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