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

Catalog Number	10438577
Medical Device Problem Codes	Mechanical Jam (2983); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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).
Event or Problem Description
It was reported that a patient underwent an atrial flutter (afl) procedure with a soundstar catheter and observed the curve getting stuck.The deflection of the soundstar catheter was not adequate.The curve was getting stuck even though the catheter was unlocked on fluoroscopy.The catheter had to be manually uncurved.The reflection knobs were getting stuck.The procedure was continued with the issue still present.No patient consequence was reported.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.
Additional Manufacturer Narrative
Additional information was received on 07-nov-2024.The curve of the catheter was stuck / jammed in a fully deflected position.The knob/piston was unable to be turned and/or pushed up and down.No difficulty in removing the catheter.The investigation was completed on 14-nov-2024.An analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed for the finished device number lot e5197070 and no internal actions related to the complaint was found during the review.If the product is received at a later date, the investigation will be updated as applicable.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.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
During further internal review on 10-mar-2025, this complaint was reassessed from h6.Medical device problem code ¿mechanical jam (a0506)¿ reportable malfunction to ¿positioning problem (a1502)¿ not reportable issue.A recurrence of the malfunction is unlikely to contribute to a death or need for medical or surgical intervention to preclude serious injury (permanent impairment to a body function, permanent damage to a body structure).Manufacturer's reference number: (b)(4).

• Brand Name: SOUNDSTAR
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 20622003
• Report Number: 2029046-2024-03578
• Device Sequence Number: 21020095
• Product Code: OBJ
• UDI-Device Identifier: 10846835008838
• UDI-Public: (01)10846835008838(17)250814(10)E5197070
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/29/2025

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: 08/14/2025
• Device Catalogue Number: 10438577
• Device Lot Number: E5197070
• 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: 10/14/2024
• Supplement Date Received by Manufacturer: 11/07/2024; 03/10/2025
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 12/03/2024; 03/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2024
• 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: UNK_SMARTABLATE GENERATOR
• Patient Sex: Unknown