MAUDE Adverse Event Report: MICROVENTION, INC. SOFIA FLOW 5F; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	DA5125ST
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was stated to be available for return to the manufacturer for evaluation but has not yet been returned.The alleged product issue/event as described could not be confirmed.If the device is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.
Event or Problem Description
As reported: dr.Said, "fibers were discovered in the catheter".Removed and replaced catheter.The patient was reported to be "good".
Additional Manufacturer Narrative
The following fields have been updated: b5 - additional information on event description.The device was returned to the manufacturer for evaluation.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.
Event or Problem Description
Additional information received reported: the physician stated that the foreign material was ¿green colored¿.It was discovered when they were introducing the sofia 5 fr into the rhv.They stopped and utilized another catheter.No other device was used inside the catheter with any resistance.Before a physician utilizes a catheter; it is standard procedure to flush the catheter on the back table.A theory is that maybe this ¿matter¿ was pushed forward ¿ only an opinion.
Additional Manufacturer Narrative
The following fields have been updated: b5 - additional information on event description items returned for investigation: -sofia catheter items not returned for investigation: -guide catheter -guide catheter rhv the catheter was returned with a clump of wire in the hub.The wire was retrieved and appeared to be tangled around a piece of polymer material.The wire was untangled and the polymer was observed to be visually consistent with ptfe, and the wire was threaded inside it.No part of the catheter was observed to have a dislodged or absent wire.Furthermore, no particulate or fibers were found on or in the lumen of the catheter, nor were any particulates or fibers observed in the pouch the device was returned in.The investigation of the returned sofia catheter found an unknown wire inside the hub.The wire was observed to have a stretched coil form and was threaded inside a tube of material visually consistent with ptfe.The investigation could not identify the origin of the wire and ptfe, but was determined to not be from the returned catheter as no section of the catheter lumen had a dislodged or missing coil.Furthermore, the additional information received regarding the reported event indicated that the catheter was flushed first and no material was observed at that time.No green colored particulate or fibers were found on or in the lumen of the catheter, nor were any particulates or fibers observed in the pouch the device was returned in.Therefore, this complaint is considered non-verifiable.The guide catheter and rhv used in the procedure were not returned for evaluation, so the investigation could not determine if they had caused or contributed to the reported complaint.
Event or Problem Description
Additional information received reported: 1."they were inserting the sofia into the rhv." when the fibers were discovered.2.They were able to flush the sofia catheter without issues prior to finding the "foreign material"."they flushed catheter on back table first, no material was found.".

• Brand Name: SOFIA FLOW 5F
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 21682146
• Report Number: 2032493-2025-00249
• Device Sequence Number: 8488463
• Product Code: DQO
• UDI-Device Identifier: 00810170019234
• UDI-Public: (01)00810170019234(11)240903(17)270831(10)0000692196
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K142014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/03/2025

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 Model Number: DA5125ST
• Device Lot Number: 0000692196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2025
• Supplement Date Received by Manufacturer: 03/24/2025; 05/29/2025
• Initial Report FDA Received Date: 03/24/2025
• Supplement Report FDA Received Date: 04/18/2025; 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2024
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown