MAUDE Adverse Event Report: BIOSENSE WEBSTER INC DEF 7F,20P,DOME,DUO-DECAPOLAR; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	D728260RT
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	08/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) procedure with a def 7f, 20p, dome, duo-decapolar and suffered cardiac tamponade requiring pericardiocentesis.It was reported that a pericardial effusion occurred during a carto procedure.It was noticed after transseptal puncture.A pericardiocentesis was performed.Physician assumed that pericardial effusion happened during catheter maneuver prior to transseptal puncture.Patient was fine and released from hospital with no consequences.The adverse event occurred on (b)(6) 2022.The physician¿s opinion on the cause of this adverse event is that it was procedure related.A smartablate generator (g4c-5196) was used in the event.Prior to noting the pericardial effusion, ablation was not performed.There was no evidence of a steam pop.The event occurred during the transseptal phase.An irrigated catheter was used in the event, the flow setting was 17/30 ml.
Additional Manufacturer Narrative
The device has been reported as unavailable; 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.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.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).

• Brand Name: DEF 7F,20P,DOME,DUO-DECAPOLAR
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-7981
• MDR Report Key: 15415836
• Report Number: 2029046-2022-02212
• Device Sequence Number: 2556592
• Product Code: DRF
• UDI-Device Identifier: 10846835004960
• UDI-Public: 10846835004960
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K953663
• 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): 09/14/2022

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: D728260RT
• Device Catalogue Number: D728260RT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2022
• Initial Report FDA Received Date: 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SMARTABLATE GENERATOR KIT-WW
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown