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

Catalog Number	10439236
Medical Device Problem Codes	Material Twisted/Bent (2981); Mechanical Jam (2983); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure with a soundstar eco and the deflection mechanism became stuck.After inserting the catheter into the cardiac cavity and performing brockenbrough, approximately one hour after using it in the left atrium (to confirm the site for ablation with farapulse) the physician reported that its behavior was different from usual.After bending the soundstar eco catheter on the p side, it did not return to the center and remained unable to become flat.It appeared to have developed a bend or kink, and even when bent on the a side, the catheter did not straighten out.Since it was just before the end of the procedure, the physician instructed not to replace the catheter, and the procedure was completed as it was.The procedure was completed without patient's consequence.Additional information received indicated the knob was able to be turned and/or pushed up and down but the catheter was stuck.The catheter could not be flattened, event when shaped by hand.
Additional Manufacturer Narrative
On 15-oct-2025, the bwi product analysis lab received the complaint device for evaluation.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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 ref.# (b)(4).
Additional Manufacturer Narrative
On 16-oct-2025, additional information was received indicating the catheter did have mobility to bend the catheter on both the a and p sides.As such, this event is no longer considered to be an mdr reportable malfunction.As such, the h6.Medical device problem code has been updated from mechanical jam (a0506) to positioning problem (a1502).Manufacturer's ref.# (b)(4).

• Brand Name: SOUNDSTAR ECO
• 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: 23318983
• Report Number: 2029046-2025-03459
• Device Sequence Number: 5134916
• Product Code: OBJ
• UDI-Device Identifier: 10846835008869
• UDI-Public: (01)10846835008869(17)260727(10)G9512335
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/27/2026
• Device Catalogue Number: 10439236
• Device Lot Number: G9512335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/28/2025
• 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: ABROAD STOUT, 8.5FR; FARAPULSE
• Patient Sex: Unknown