MAUDE Adverse Event Report: BIOSENSE WEBSTER INC WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	D135303
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	03/18/2020
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.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 a cryo atrial fibrillation ablation procedure with a webster cs catheter with auto id technology and suffered a cardiac tamponade requiring pericardiocentesis.During the procedure, the patient became hypotensive and a cardiac tamponade was confirmed by transthoracic esophageal echo (tee).A pericardiocentesis was performed to remove an unspecified amount of fluid from the pericardial space.The patient was reported in stable condition after pericardial drainage.It is unknown if extended hospitalization was required as a result of the adverse event.Patient recovered.The physician did not attribute the causality of the adverse event to the biosense webster, inc.(bwi) product but to cryo.The only bwi catheter that was in use at the time of the injury was the webster cs catheter with auto id technology.No radio frequency delivery was applied with any bwi product during the procedure.No visitags were used.Initially, since the physician attributed the causality of the event to cryo (non-bwi product) and no bwi ablation catheter was used during the procedure, the webster cs catheter with auto id technology was assessed as a concomitant product and therefore, not mdr reportable.Further review was performed on april 21, 2020 and the re-assessment was made to conservatively report this event under the bwi webster cs catheter with auto id technology as there is no clarity on the timing of the event and its relationship to the catheter use.The awareness date for this re-assessment for this record is april 21, 2020.

• Brand Name: WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 10058168
• Report Number: 2029046-2020-00606
• Device Sequence Number: 11478547
• Product Code: DRF
• UDI-Device Identifier: 10846835009972
• UDI-Public: 10846835009972
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K080425
• 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): 03/18/2020

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: D135303
• Device Catalogue Number: D135303
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2020
• Initial Report FDA Received Date: 05/14/2020
• 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