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	05/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) procedure with a reprocessed soundstar eco 8f diagnostic ultrasound catheter and when the catheter was removed from the packaging, there was some plastic melted onto the tip of the catheter.The package was opened during prep for the surgery while the patient was on the table.There was no physical damage, or any other issue observed on the package of the device.The catheter was replaced, and the procedure continued without further issues.There was no patient consequence.
Additional Manufacturer Narrative
The product analysis lab received the device for evaluation.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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
According to the information received, during an atrial fibrillation (afib) procedure, it was discovered that when the reprocessed soundstar eco 8f diagnostic ultrasound catheter (r10439011/2189460) was removed from the packaging there was some plastic melted onto the tip of the reprocessed catheter.The catheter was replaced, and the procedure continued without further issues.The device was returned to sterilmed for further evaluation.A non-sterile reprocessed soundstar eco 8f diagnostic ultrasound catheter was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and the transitional piece was found rolled-up, backwards, and stuck at the distal tip of the device.The serial number label was missing, and the physical mark on the device indicated that it had been reprocessed one (1) time.The distal end of the catheter was inspected under magnification, and the tip was found bent at the transition of the tip and the shaft.The transitional piece was dissected, and residues of the label was found.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.The issue reported regarding the plastic material was confirmed based on the findings mentioned above; however, it is suggested that the transitional piece and label tag could have been rolled-up during the removal of the catheter from its packaging.The bent condition on the tip of the catheter was not originally reported; however, there is no indication that the issue reported in the complaint is a result of a defect inherently related to the device.As part of sterilmed's quality process, all devices are manufactured, inspected, and released to approved specifications.Devices undergo 100% inspection at different points during the manufacturing process to prevent defective devices from leaving the facility.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (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 ; 303552-6892
• MDR Report Key: 17020700
• Report Number: 2134070-2023-00017
• Device Sequence Number: 7150912
• Product Code: OWQ
• UDI-Device Identifier: 10888551045087
• UDI-Public: 10888551045087
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 05/30/2023

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: 03/20/2024
• Device Model Number: R10439011
• Device Catalogue Number: R10439011
• Device Lot Number: 2189460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2023
• Supplement Date Received by Manufacturer: 06/29/2023
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 07/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2023
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown