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

Catalog Number	10439011
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation details: the product was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Visual inspection and soundstar magnetic, recognition, and visualization test were performed following bwi procedures.Visual analysis revealed broken shaft exposing internal components.No other issues were observed.Magnetic, recognition, and visualization test were performed and the catheter was recognized; however, error 6150 appeared on the system due to an open circuit from dissection to the connector.A device history record evaluation was performed for the finished device, and no internal actions related to the complaint were found during the review.The magnetic issue reported by the customer was confirmed.The potential cause of the broken shaft and open circuit cannot be determined.The broken shaft issue is unrelated to the reported event.The instructions for use (ifu) contain the following warning stated in the carto 3 system manual: the magnetic sensor of the catheter is disconnected.To continue, replace the catheter cable.If that does not resolve the problem, replace the catheter.Do not use if package is damaged.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: rod/shaft (g04112) were selected as related to the broken shaft identified by bwi pal.Investigation findings: open circuit (c0205) / investigation conclusions: cause not established (d15) / component code: electrical lead/wire (g02015) were selected as related to error 6150.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 a right atrial flutter (r-afl) ablation procedure with a soundstar for which biosense webster¿s product analysis lab (pal) identified a broken shaft which exposed the internal components.It was initially reported by the customer that the soundstar® catheter had a catheter sensor error (error#6150) displayed on the carto® 3 system.The cable was replaced without resolution.The catheter was replaced and the problem was resolved.The case continued.There was no patient consequence.The customer's reported magnetic sensor error is not considered to be mdr reportable since the potential risk that it could cause or contribute to a serious injury or death to the operator or patient is remote.On 27-aug-2024, the bwi pal revealed that a visual inspection of the returned device found a broken shaft which exposed the internal components.These findings were reviewed and assessed as an mdr reportable malfunction since the integrity of the device has been compromised.

• 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: 20259890
• Report Number: 2029046-2024-03162
• Device Sequence Number: 18145890
• Product Code: OBJ
• UDI-Device Identifier: 10846835008852
• UDI-Public: (01)10846835008852(17)250408(10)E8549693
• 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

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: 04/08/2025
• Device Catalogue Number: 10439011
• Device Lot Number: E8549693
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2024
• 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: CARTO 3 SYSTEM; UNKNOWN CABLE
• Patient Sex: Unknown