MAUDE Adverse Event Report: STERILMED, INC.; CATHETER, ELECTRODE RECORDING

Catalog Number	R10439011
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a reprocessed soundstar eco 8f diagnostic ultrasound catheter and the catheter curled in the lower abdomen when inserted into the patient.The catheter was unable to uncurl.An attempt was made to straighten out the catheter by advancing to the right atrium and pulling back to the inferior vena cava.However, the catheter had to be removed by removing the sheath and catheter.There was a 20-minute delay.The procedure was successfully completed.There was no patient injury or consequence.
Additional Manufacturer Narrative
The device has not yet been returned for analysis.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 atrial fibrillation (afib) ablation procedure with a reprocessed soundstar eco 8f diagnostic ultrasound catheter and the catheter curled in the lower abdomen when inserted into the patient.The catheter was unable to uncurl.The device was returned to sterilmed for further evaluation on 16-jun-2025.A non-sterile reprocessed soundstar eco 8f diagnostic ultrasound catheter for use on siemens imaging system was received contained in the decontamination bag.Upon received the device, a visual inspection was performed, and the shaft was found to be curved, with the curvature beginning at the top.It was impossible to return the shaft to its original position.Additionally, multiple compressions were found on the shaft of the catheter, and adhesive residue was found on the catheter's handle.The physical mark on the device indicated that it had been reprocessed one (1) time.The catheter was inspected with x-rays, and the damaged area was found to have several kinks inside the shaft of the device.The deflection mechanism was dissected, and no damage was found on the puller wire.A device history record (dhr) was performed, and no internal actions were identified.The issue regarding the shaft being unable to uncurl was confirmed based on the presence of several kinks, as mentioned in the above findings.With the limited information available, a conclusive cause cannot be determined; however, the complaint was reported to have occurred intra-operatively, the device was already manipulated before the issue was found, and factors not described within the information available, such as device manipulation, may have contributed to the issue encountered.There is no indication that the issue reported in the complaint is a result of a defect inherently related to the device.The multiple compress on the shaft was not originally reported, and the exact time of occurrence cannot be determined; therefore, this is not considered related to the issue reported.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 damages 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: NA
• 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: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 22176413
• Report Number: 2134070-2025-00009
• Device Sequence Number: 7788705
• Product Code: OWQ
• UDI-Device Identifier: 10888551045087
• UDI-Public: (01)10888551045087(17)260123(10)2230007
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161700
• 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

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: 01/23/2026
• Device Catalogue Number: R10439011
• Device Lot Number: 2230007
• 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: 05/22/2025
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2025
• 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