MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. WEBSTER ® CS CATHETER WITH EZ STEER® THECHNOLOGY AND AUTO ID; ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE

Catalog Number	BD710DF282CT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Myocardial Infarction (1969); No Code Available (3191)
Date of Event	07/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.The manufacturing record evaluation cannot be conducted because no lot number was provided by the customer.(b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a webster ® cs catheter with ez steer® technology and auto id and suffered possible myocardial infraction (mi) requiring surgical intervention.During the procedure, myocardial infraction was discovered by the anesthesia vitals.The caller reported that the mi has not been confirmed yet.The medical intervention provided was a balloon pump and a cardiac catheterization.After cardiac catheterization, the result was negative.The patient was reported in stable condition.The procedure went forward as scheduled.It is suspected that patient had coronary event at beginning of procedure that then resolved.Ablation was not performed during the case.No issues were attributed to equipment or procedure.The procedure was completed as it was originally intended.There¿s no information regarding extended hospitalization or physician causality opinion.

• Brand Name: WEBSTER ® CS CATHETER WITH EZ STEER® THECHNOLOGY AND AUTO ID
• 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: 8857917
• Report Number: 2029046-2019-03493
• Device Sequence Number: 1903867
• Product Code: DRF
• UDI-Device Identifier: 10846835002409
• UDI-Public: 10846835002409
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 07/15/2019

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 Catalogue Number: BD710DF282CT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 08/02/2019
• 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