MAUDE Adverse Event Report: BIOSENSE WEBSTER INC EZ STEER NAV DS BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	BN7TCDD8L
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	08/04/2021
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.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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) male patient ((b)(6)) underwent an atrial flutter right (r-afl) ablation procedure with ez steer" nav bi-directional electrophysiology catheter and suffered cardiac arrest requiring cpr, defibrillator and medication.During an atrial flutter right sided, on (b)(6) 2021 at approximately 1p the patient coded.The patient did not have a pulse and it was confirmed by the recording system and by the physician.The patient received cpr and medication (unknown type) and the pulse was restored, and the blood pressure restored to normal range as well.No ablation had occurred, and they were preforming entrainment mapping when the issue occurred.The patient was reported to be in stable condition.The adverse event was discovered while ez steer" nav ds bi-directional electrophysiology catheter was in the right atrium (ablator) and coronary sinus (webster ¿ cs catheter with ez steer" technology).No ablation had occurred prior to the event.The physicians opinion on the cause of this adverse is that this is patient condition related.The ef was low to begin with, and the physician was not positive on what happened but referred to it as a transient asystole.Code team intervention was required, and cpr was administered, defibrillator used.The patient outcome of the adverse event was reported as fully recovered (no residual effects).It is unknown if the patient required extended hospitalization because of the adverse event.
Additional Manufacturer Narrative
If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) during an internal review on 31-aug-2021, it was noticed that the physician¿s name and reporter state were inadvertently left out on the initial report.Therefore, e 1.Initial reporter title, e 1.Initial reporter first name, e 1.Initial reporter last name, and e1.Initial reporter state were updated.

• Brand Name: EZ STEER NAV DS BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• MDR Report Key: 12391726
• Report Number: 2029046-2021-01447
• Device Sequence Number: 3476493
• Product Code: OAD
• UDI-Device Identifier: 10846835002980
• UDI-Public: 10846835002980
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P010068/S6
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2021

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 Model Number: BN7TCDD8L
• Device Catalogue Number: BN7TCDD8L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2021
• Supplement Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 08/31/2021
• Supplement Report FDA Received Date: 08/31/2021
• 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: BI DIR 7FR DEFL CS CATH, NON-; BI DIR 7FR DEFL CS CATH, NON-
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 102