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
If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (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.Since this event (cardiac tamponade) is life threatening and required interventions to prevent permanent impairment of a body function or permanent damage to a body structure, then is to be considered serious and mdr-reportable.
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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
The biosense webster, inc.(bwi) product analysis lab received the device for evaluation on 3/31/2021.The device evaluation was completed on 4/14/2021.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 bwi catheter being used at the time was a soundstar catheter.The patient was reported to be in stable condition.Visual analysis of the returned sample revealed that it was in good normal condition.Then, deflection test was performed, and it was found within specifications, the catheter was deflecting correctly.Then, carto 3 visualization, acuson ultrasound and atlas transducer tests were performed, and the device passed the tests.A manufacturing record evaluation (mre) was performed for the finished device e5094029 number, and no internal actions related to the complaint was found during the review.Based on the completed mre, the h4.Device manufacture date has been populated with 9/24/2020.As part of bwi¿s quality process all devices are manufactured, inspected, and released to approved specifications.No malfunction was observed during the product analysis.The described event could not be confirmed since the device performed without any problem.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (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: 11555987
• Report Number: 2029046-2021-00395
• Device Sequence Number: 4087598
• Product Code: OBJ
• UDI-Device Identifier: 10846835008838
• UDI-Public: 10846835008838
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K112050
• 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,Followup
• Report Date (Section B): 02/26/2021

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2021
• Supplement Date Received by Manufacturer: 03/15/2021; 04/14/2021
• Initial Report FDA Received Date: 03/23/2021
• Supplement Report FDA Received Date: 04/08/2021; 05/07/2021
• 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