MAUDE Adverse Event Report: BIOSENSE WEBSTER INC SOUNDSTAR ECO 8FG ULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	10439011
Medical Device Problem Codes	Contamination /Decontamination Problem (2895); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure with a soundstar eco 8fg ultrasound catheter and a debris was found on the catheter.It was reported that when the catheter was opened, there was a debris found on the soundstar catheter.The color and size of the debris are ¿difficult to understand¿.¿swept the debris away and used¿.The customer found the foreign matter, but the customer used it on the patient after the foreign matter was removed.A picture was provided, and an explanation was provided as well, stating that this foreign substance is found after it was used.This foreign object is different from the foreign object found at the time of opening the package.It was also reported that the catheter was not recognized on the ultrasound machine.Reconnecting the cable did not solve the problem.When the catheter was replaced, the issue was resolved.No adverse patient consequence was reported.The ultrasound recognition issue was assessed as not mdr reportable.
Additional Manufacturer Narrative
If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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).
Additional Manufacturer Narrative
It was reported that a patient underwent a cardiac ablation procedure with a soundstar eco 8fg ultrasound catheter and a debris was found on the catheter.It was reported that when the catheter was opened, there was a debris found on the soundstar catheter.The color and size of the debris are ¿difficult to understand¿.¿swept the debris away and used¿.The customer found the foreign matter, but the customer used it on the patient after the foreign matter was removed.A picture was provided, and an explanation was provided as well, stating that this foreign substance is found after it was used.This foreign object is different from the foreign object found at the time of opening the package.Device evaluation details: the product was received at biosense webster (bwi) product analysis lab for evaluation on 18-aug-2023.Visual inspection and soundstar magnetic, recognition, and visualization test were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.No debris residues were observed.The soundstar magnetic, recognition, and visualization test was performed, and no ultrasound recognition issues were detected during the analysis.According to the picture provided by the customer, foreign material was observed on the shaft of the catheter; however, during the product analysis, no debris residues were observed.Device history record (dhr) was performed for the finished device e8439963 number, and no internal actions related to the reported complaint condition were identified.Based on the completed dhr the manufactured date and expiration date have been provided.Therefore, fields d4.Expiration date and h4.Device manufacture date have been populated with appropriate information.The issue reported by the customer could not be replicated during the product investigation.Other issues or circumstances may have occurred during the usage of the device that compromised its performance.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the customer¿s reported debris found on the catheter.Investigation findings: appropriate term/code not available (c22) / investigation conclusions: cause not established (d15) were selected as related to the photo analysis.Investigation findings: inappropriate material (c0602) / investigation conclusions: cause not established (d15) were selected as related to the photo analysis in regards to the foreign material reported.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 ECO 8FG ULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER
• 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: 17367622
• Report Number: 2029046-2023-01555
• Device Sequence Number: 5928969
• Product Code: OBJ
• UDI-Device Identifier: 10846835008852
• UDI-Public: 10846835008852
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2023

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: 02/02/2024
• Device Model Number: 10439011
• Device Catalogue Number: 10439011
• Device Lot Number: E8439963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2023
• Supplement Date Received by Manufacturer: 08/18/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 09/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2023
• 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: SOUNDSTAR ECO SMS 8F CATHETER.; UNK BRAND CABLE.
• Patient Sex: Unknown