MAUDE Adverse Event Report: BIOSENSE WEBSTER INC BI DIR 7FR DEFL CS CATH, NON-; ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE

Catalog Number	BD710DF282RTS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	11/18/2019
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.We are working on the manufacture record evaluation (mre), once we get more information it will be submitted in the supplemental.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 ischemic ventricular tachycardia ablation procedure with a webster ® cs catheter with ez steer¿ technology and suffered cardiac tamponade requiring pericardiocentesis.During the procedure the patient had a cardiac tamponade.Pericardiocentesis was performed and 900 ccs of fluid were removed from the pericardial space.The patient was stabilized and transferred to the coronary care unit for observation.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.

• Brand Name: BI DIR 7FR DEFL CS CATH, NON-
• Common Device Name: ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 9473150
• Report Number: 2029046-2019-03995
• Device Sequence Number: 2648248
• Product Code: DRF
• UDI-Device Identifier: 10846835002416
• UDI-Public: 10846835002416
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K090898
• 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): 11/18/2019

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: 07/26/2022
• Device Catalogue Number: BD710DF282RTS
• Device Lot Number: 30266981M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2019
• Initial Report FDA Received Date: 12/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1