MAUDE Adverse Event Report: BIOSENSE WEBSTER INC SOUNDSTAR ECO 8FG ULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Catalog Number	10439011
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	05/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The report indicated during atrial fibrillation ablation procedure a soundstar catheter was inserted in the patient, but after application of dc (direct current) to stop fibrillation, the patient has bradycardia requiring pacemaker implantation.During pafib (persistent atrial fibrillation) procedure, a soundstar catheter was inserted into the heart before bradycardia occurred.The medical team indicated that the patient was going to be treated for persistent atrial fibrillation procedure (atrial fibrillation persisted from before admission to after entering the room).After the patient entered the room, dc was used to stop the fibrillation, but bradycardia occurred, making it no longer safe to continue the procedure.Implantation of a pacemaker was considered necessary.The procedure was canceled at the physician's discretion and not canceled due to a malfunction of the ep (electrophysiology) products.Additionally, there were air bubbles upstream in the tube.The air bubbles were not embedded in the tube material itself.There were no signs of air moving even after tapping.The tubing set was with another new one.The catheters were discarded in the hospital because the procedure was discontinued.The procedure was completed without patient's consequence.Intervention provided was pacemaker implantation needed.The physician¿s comment on relationship between the event and the product was no relationship.The outcome of the adverse event was unchanged.The symptoms did not worsen.No abnormalities observed prior/during use of the product.
Additional Manufacturer Narrative
D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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).
Additional Manufacturer Narrative
Per internal review on 22-jul-2025, it was determined that this event is not fda reportable against any bwi device.The bradycardia is clinically concluded to be due to post cardioversion, as bradycardia is most likely a consequence of sinus node dysfunction or an underlying patient condition rather than the ice (intracardiac echocardiography) catheter.There is no indication the ice catheter contributed to the adverse event and no malfunction with the ice catheter that would cause it to be a suspected device.Additionally, the stsf, pentaray and lasso catheter were not used and therefore also not suspected devices.Lastly, the physician said there were no causal relationship between the bradycardia and bwi products.No further reports will be sent for this event.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2025, the adverse event was discovered during use.The soundstar catheter had been inserted into the heart before bradycardia occurred.Other bwi products were not inserted into the patient¿s body.The physician¿s opinion on the cause of this adverse event was that there was no causal relationship between the bradycardia and bwi products.The patient did not require extended hospitalization.Relevant tests/laboratory data was preoperatively atrial fibrillation was observed.After that bradycardia was observed.Other relevant history/preexisting condition was persistent atrial fibrillation.Section b7 medical history/preexisting condition was updated accordingly with the patient's afib.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 ECO 8FG ULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): SIEMENS LTD. SEOUL; venture bldg 2, office 112 601; pohang technopark, jigok-dong; gyeongbuk 790-8 34; KS 790-834
• Manufacturer Contact: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 22137405
• Report Number: 2029046-2025-01804
• Device Sequence Number: 17981006
• Product Code: OBJ
• UDI-Device Identifier: 10846835008852
• UDI-Public: 10846835008852
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/14/2025

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: 02/11/2026
• Device Catalogue Number: 10439011
• Device Lot Number: E8621129
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2025
• Supplement Date Received by Manufacturer: 06/18/2025; 07/22/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 07/14/2025; 08/12/2025
• 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: LASSO NAV 2515,22P SPLITHANDLE.; PENTARAY NAV ECO 7FR, D, 2-6-2.; SMARTABLATE IRR TUBE SET.; THMCL SMTCH SF BID, TC, D-F.
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Male
• Patient Weight: 72 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian