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

Catalog Number	R10439011
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2024
Type of Reportable Event	Malfunction
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).
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 when the tray was opened, the tip dome portion of the catheter slid off.There was no damage to the packaging.There was no patient consequence.
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 when the tray was opened, the tip dome portion of the catheter slid off.The device was returned to sterilmed for further evaluation on 12-nov-2024.A non-sterile reprocessed soundstar eco 8f diagnostic ultrasound catheter was received contained in the decontamination bag.Upon product receipt, a visual inspection was performed and the upper part of the handle was detached.No other damage was observed.The physical part on the device indicated that the device had been reprocessed one (1) time.A device history review (dhr) was performed, and no internal actions were identified.The issue reported was not confirmed since the tip of the device was found without damages.There may have been other circumstances that occurred during the use of the device that could not be replicated in the lab setting.No further analysis can be performed without the package of the catheter.The detached condition of the handle 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.Section d9 was updated.Section h6 codes c19 and d14 are in regards to the originally reported tip issue.Codes c07 and d15 are for the handle issue found during investigation.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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 20583346
• Report Number: 2134070-2024-00021
• Device Sequence Number: 18169292
• Product Code: OWQ
• UDI-Device Identifier: 10888551045087
• UDI-Public: (01)10888551045087(17)250724(10)2217853
• 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: 07/24/2025
• Device Catalogue Number: R10439011
• Device Lot Number: 2217853
• 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: 10/09/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 10/31/2024
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2024
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown