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

Catalog Number	BN7TCFJ4L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	05/07/2019
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.On 5/15/2019, a manufacturing record evaluation was performed for the finished device 30174785m number, and no non-conformances was found during the review.Manufacture reference no: (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrioventricular reentrant tachycardia (avrt)/wolff-parkinson-white syndrome (wpw) ablation procedure with an ez steer¿ nav bi-directional electrophysiology catheter and suffered cardiac tamponade requiring pericardiocentesis.During the procedure, when the agilis sheath was advanced over the biosense webster inc.(bwi) ablation catheter, the catheter tip did not disappear, leading the physician to believe the sheath was more proximal than it was.The sheath continued to be advanced and perforated the right atrial appendage.The patient became hypotensive, and cardiac tamponade was confirmed by transesophageal echocardiogram (tee).Pericardiocentesis was performed to remove 260 cc of fluid from the pericardium.The patient was reported in stable condition.There¿s no information regarding extended hospitalization or physician causality opinion.No bwi product malfunctions were reported.It was reported that the agilis sheath (non-bwi product) perforated the right atrial appendage; however, the bwi ablation catheter was also in use at that time.With the available information, it cannot be confirmed the usage of the bwi product did not contributed to the causality of the event; therefore, this event will be reported under the bwi product.Multiple attempts have been made to gain clarification on this event with no response.Should any new information be obtained it will be assessed and processed accordingly.

• 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: 8655783
• Report Number: 2029046-2019-03187
• Device Sequence Number: 19290703
• Product Code: LPB
• UDI-Device Identifier: 10846835003031
• UDI-Public: 10846835003031
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 05/07/2019

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 Expiration Date: 01/29/2022
• Device Catalogue Number: BN7TCFJ4L
• Device Lot Number: 30174785M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/07/2019
• Initial Report FDA Received Date: 05/30/2019
• 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