MAUDE Adverse Event Report: BIOSENSE WEBSTER INC WEBSTER ELECTROPHYSIOLOGY CATHETER; ELECTRODE, PACEMAKER, TEMPORARY

Model Number	F5QA252RT
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	08/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30416910m number, and no internal action related to the complaint was found during the review.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 nodal reentrant tachycardia (avnrt) ablation procedure with a webster¿ electrophysiology catheter and suffered cardiac tamponade (ct) requiring pericardiocentesis.It was reported that a pericardial effusion was noted post use of biosense webster products.The cause is unknown; however, the physician's opinion on the cause is that it is procedure related and not catheter related.A pericardial puncture was performed to drain blood.The procedure was successfully completed.The patient outcome was reported as ¿improved, on that day, no further information at the moment¿.The patient required extended hospitalization for monitoring.Transseptal puncture was performed with an abbott brk needle.Prior to noting the ct, ablation was performed.There was no evidence of a steam pop.It is unknown at what phase the event occurred; however, it was detected post procedure.An irrigated catheter was used in the event and the flow settings were: 8ml/min up to 30w, 15ml/min above 30w.The correct catheter settings were selected on the generator.The pump was switching from low to high flow during ablation.No error messages were observed on biosense webster equipment during the procedure.Force visualization features used were: graph & vector with the visitag module parameters for stability set at: 3;3;25;3 tag size 3 with no additional filter used with the visitag.The color option used prospectively was ai.

• Brand Name: WEBSTER ELECTROPHYSIOLOGY CATHETER
• Common Device Name: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• MDR Report Key: 12513575
• Report Number: 2029046-2021-01609
• Device Sequence Number: 1139439
• Product Code: LDF
• UDI-Device Identifier: 10846835007213
• UDI-Public: 10846835007213
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K892265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/26/2021

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: 07/28/2023
• Device Model Number: F5QA252RT
• Device Catalogue Number: F5QA252RT
• Device Lot Number: 30416910M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 09/22/2021
• 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: ABBOTT BRK TRANSSEPTAL NEEDLE; DEF 7F,BRD,TC,4P,F,LE,252,RDL; UNK_CARTO 3
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention