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

Catalog Number	10439072
Medical Device Problem Codes	Communication or Transmission Problem (2896); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2024
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 a cardiac ablation procedure with a soundstar and after the order was reviewed, the outer box and the inside carton of the soundstar® catheter were found broken and the connector on the catheter was also broken.The damage was found on the proximal most part of the catheter at the swift link connection.The reporter requested a replacement for the soundstar® catheter.The damage resulted in wires/internal components being exposed.The damage did not result in any lifted or sharp rings.The catheter was not used in the procedure, as the damage was evident when removed from packaging.No adverse patient consequence was reported.
Additional Manufacturer Narrative
It was reported that a patient underwent a cardiac ablation procedure with a soundstar and after the order was reviewed, the outer box and the inside carton of the soundstar® catheter were found broken and the connector on the catheter was also broken.The damage was found on the proximal most part of the catheter at the swift link connection.The reporter requested a replacement for the soundstar® catheter.The damage resulted in wires/internal components being exposed.The damage did not result in any lifted or sharp rings.The catheter was not used in the procedure, as the damage was evident when removed from packaging.No adverse patient consequence was reported.Device investigation details: the device was returned to johnson & johnson medtech (j&j medtech) for evaluation.A visual inspection was performed in accordance with j&j medtech procedures.Visual analysis revealed that the connector was broken.No other damages or anomalies were observed.A device history review was performed for the finished device number lot g4151495 and no internal action related to the complaint was found during the review.The connector and internal component exposed issues reported by the customer were confirmed.The potential cause of the broken condition could be related to the manipulation of the device before the procedure; however, this could not be conclusively determined.The instruction for use (ifu) of the device contain the following recommendations: inspect the entire soundstar® catheter for damage; inspect the swiftlink¿ connector for damage; do not use the soundstar® catheter if the packaging is open or damaged.As part of johnson & johnson medtech¿s quality process, all devices are manufactured, inspected, and released 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).

• 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: 21049386
• Report Number: 2029046-2024-04194
• Device Sequence Number: 3277381
• Product Code: OBJ
• UDI-Device Identifier: 10846835008845
• UDI-Public: (01)10846835008845(17)251015(10)G4151495
• Combination Product (Y/N): N
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2025

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: 10/15/2025
• Device Catalogue Number: 10439072
• Device Lot Number: G4151495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2024
• Supplement Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 12/31/2024
• Supplement Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2024
• 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
• Patient Sex: Unknown