MAUDE Adverse Event Report: STERILMED, INC. SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER; CATHETER, ELECTRODE RECORDING

Model Number	R10439011
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) procedure with a soundstar eco 8f diagnostic ultrasound catheter and a foreign matter inside the packaging issue occurred.Inside the sterile packaging of the reprocessed catheter, it had some black specks of a foreign substance.They could see it through the packaging so they decided not to open it.The catheter was replaced with another reprocessed catheter and the issue was resolved.This is the only catheter that they found to have this issue in the account inventory.The procedure continued.There was no patient consequence reported.Additional information was received.The catheter with the lot number of 2176602 had the foreign substance in sterile package issue.The box was opened, but not the sterile packaging.There was no physical damage or any other issue observed on the package of the device with the foreign substance (outer box, tray, pouch).The foreign substance was loose in the package, not on the device.Pictures are not available, but package was unopened.The catheter was left in the sterile packaging.The outer box is not available.The event was assessed as mdr reportable for foreign matter inside the packaging issue.
Additional Manufacturer Narrative
The sterilmed product analysis lab received the device for evaluation on 22-mar-2023.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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 sterilmed, inc, or its employees that the report constitutes an admission that the product, sterilmed, 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 ref.No: (b)(4).
Additional Manufacturer Narrative
It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) procedure with a soundstar eco 8f diagnostic ultrasound catheter and a foreign matter inside the packaging issue occurred.The device evaluation was completed on 19-jul-2023.The device was returned to sterilmed for evaluation.A non-sterile reprocessed soundstar eco 8f diagnostic ultrasound catheter was received in its original sealed pouch.Visual inspection was performed, and black particles were observed adhered to the pouch and along the length of the catheter.The physical mark on the catheter indicated that it had been reprocessed one (1) time.The particles were submitted to fourier transformed infrared spectroscopy (ft-ir) analysis, and it was concluded that the foreign material is primarily composed of a biological-base material.The device history records (dhr) for lot number 2176602 were reviewed and no evidence of deficiencies related to the reported complaint was found during the manufacturing process.No internal actions were generated during the manufacturing process.Complaint history for product code r10439011 (soundstar eco 8f diagnostic ultrasound catheter), found no similar events reported.The reported event was confirmed based on the appearance of the returned device.The ft-ir results and the confirmed condition observed on the returned device suggest that the issue occurred after the final intended point of detection.An internal corrective action has been opened to investigate this issue.As part of sterilmed¿s quality process all devices are manufactured, inspected, and released to approved specifications.This issue is being addressed through sterilmed¿s quality system.H6.Component code of ¿appropriate term/code not available¿ represents foreign matter.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 8F DIAGNOSTIC ULTRASOUND CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• Manufacturer (Section G): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16598965
• Report Number: 2134070-2023-00010
• Device Sequence Number: 1700110
• Product Code: OWQ
• UDI-Device Identifier: 10888551045087
• UDI-Public: 10888551045087
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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
• Report Date (Section B): 08/16/2023

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: 07/21/2023
• Device Model Number: R10439011
• Device Catalogue Number: R10439011
• Device Lot Number: 2176602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2023
• Supplement Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 03/23/2023
• Supplement Report FDA Received Date: 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2022
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER.; SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER.; UNKNOWN BRAND CATHETER.; UNKNOWN BRAND ECO CABLE.; UNKNOWN BRAND ECO CABLE.; UNK_CARTO 3.
• Patient Sex: Unknown