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

Model Number	BN7TCFF4L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	05/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrioventricular reentrant nodal tachycardia (avrnt) ablation procedure with an ez steer¿ nav bi-directional electrophysiology catheter and suffered cardiac tamponade.At an unspecified point, the patient developed a cardiac tamponade.It is unknown at this time how it was discovered and what type of medical intervention was provided.There¿s no indication that extended hospitalization was required as a result of the adverse event.Physician¿s causality opinion was not provided.The patient was reported to be in stable condition.No biosense webster, inc.Product malfunctions were reported.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.

• Brand Name: EZ STEER NAV 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: 10132967
• Report Number: 2029046-2020-00674
• Device Sequence Number: 2823477
• Product Code: LPB
• UDI-Device Identifier: 10846835003017
• UDI-Public: 10846835003017
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P990025/S12
• 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): 05/13/2020

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 Model Number: BN7TCFF4L
• Device Catalogue Number: BN7TCFF4L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2020
• Initial Report FDA Received Date: 06/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 7 FR DECAN, 11P, D, 2.4 MMLE, 282 MM
• Outcome Attributed to Adverse Event: Life Threatening