MAUDE Adverse Event Report: BIOSENSE WEBSTER INC SOUNDSTAR; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	10438577
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	02/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's reference number: (b)(4).This event was also reported by the manufacturer under mdr #2029046-2021-00395.Reference# (b)(4).
Event or Problem Description
It was reported that a patient underwent a cryo atrial fibrillation cardiac ablation procedure with a soundstar and suffered cardiac tamponade requiring pericardiocentesis.A pericardial effusion was noticed after they went transseptal.There were no visible signs on the patient.The pericardial effusion was confirmed by intracardiac echocardiography (ice).The medical intervention provided was a pericardiocentesis and about 400ml of fluid was removed.No ablation catheters were in the body and the only biosense webster, inc.(bwi) catheter being used at the time was a soundstar catheter.The patient was reported to be in stable condition.The physician did not mention the cause of the pericardial effusion.
Additional Manufacturer Narrative
Additional information was received on 3/15/2021 and it was reported that the physician's opinion on the cause of this adverse event was that it was procedure related.Pericardiocentesis/pericardial window was required.The patient required extended hospitalization because of the adverse event.Therefore, "b2.Is hospitalization initial/prolonged" box was checked and "h6: health effect - impact code" was populated with hospitalization or prolonged hospitalization on this report.The patient was reported to have fully recovered.A transseptal puncture was performed with a brk-1 needle.Therefore, the concomitant products section of this report was populated with "unknown brand brk 1 needle".Ablation was not performed prior to noticing the cardiac tamponade.There was no evidence of a steam pop.No error messages were observed on the biosense webster, inc.Equipment during the procedure.The biosense webster, inc.Product analysis lab received the device on 03/31/2021 for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Manufacturer's reference number: (b)(4).This event was also reported by the manufacturer under mdr #2029046-2021-00395.Reference# (b)(4).

• Brand Name: SOUNDSTAR
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 11569672
• Report Number: 3023245-2021-00006
• Device Sequence Number: 17049413
• Product Code: OBJ
• UDI-Device Identifier: 10846835008838
• UDI-Public: 10846835008838
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2021
• Report Date (Section F): 03/24/2021

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 Expiration Date: 09/23/2021
• Device Model Number: 10438577
• Device Catalogue Number: 10438577
• Device Lot Number: E5094029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/18/2021
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 04/28/2021
• 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: UNKNOWN BRAND BRK 1 NEEDLE
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Date Report Sent to FDA: 03/24/2021