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

Catalog Number	10439011
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a soundstar and the catheter tip was broken.The device was exchanged to continue.There was no patient consequence reported.Device investigation details: an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.However, if the product or product id numbers are 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.Note: for field d4: udi: as the lot number for the device involved in the event was not provided, the full udi is not available.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a soundstar and the catheter tip was broken.The device was exchanged to continue.There was no patient consequence reported.
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.Note: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.Manufacturer's ref.# (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: 19923881
• Report Number: 2029046-2024-02622
• Device Sequence Number: 18171075
• Product Code: OBJ
• UDI-Device Identifier: 10846835008852
• UDI-Public: 10846835008852
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: 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 Catalogue Number: 10439011
• 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: 07/10/2024
• Supplement Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 09/04/2024
• 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
• Patient Sex: Unknown