MAUDE Adverse Event Report: MICROVENTION, INC. SOFIA FLOW PLUS 6F; PERCUTANEOUS CATHETER

Model Number	DA6125ST-ASP-US-OD
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during aspiration in a stroke case, the sofia aspiration catheter broke between the hub and catheter when being pulled.The physician removed the catheter and confirmed nothing was left in the patient.There was no reported patient injury or clinical sequela.
Additional Manufacturer Narrative
A search for non-conformances associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.If the device or additional information is received, microvention, inc., will submit a supplemental report.Instructions for use (ifu) includes following warnings and precautions: inspect the sofia¿ catheter prior to use.Do not use the device if any damages or irregularities are observed.The sofia¿ catheter should be manipulated under fluoroscopic guidance.Do not advance or withdraw the device when excessive resistance is met until the cause of resistance is determined.Torquing the sofia¿ catheter excessively while kinked may damage the device resulting in separation of the device.Withdraw the entire device (the device, microcatheter, and guidewire) if the device is severely kinked.Precautions: exercise care in handling the sofia¿ catheter to reduce the chance of accidental damage.
Additional Manufacturer Narrative
Summary device evaluation: the investigation of the returned sofia found that the hub was separated from the proximal end of the catheter.The distal section of the returned catheter hub was inspected and was found with a small filet of uv glue.The investigation determined that this condition is consistent with an inadequate adhesion of the hub to the catheter shaft.Insufficient adhesion between the hub and the catheter would result in the hub coming off, which is consistent with the alleged product issue.The findings from this investigation have been communicated to quality.
Additional Manufacturer Narrative
Additional information: h10.Additional information received.The physician stated the catheter was inspected briefly and it looked normal.Issue occurred when the device was withdrawn from patient's body after aspiration was applied.No issues advancing the catheter inside the vessel.No excessive torqueing was applied.There was resistance when withdrawing the catheter from the patient's body.The hub was loosened.Anatomy was slightly tortuous but manageab.The device was returned to the manufacturer for analysis; however, investigation is not complete and still ongoing.

• Brand Name: SOFIA FLOW PLUS 6F
• Common Device Name: PERCUTANEOUS CATHETER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 14032664
• Report Number: 2032493-2022-00137
• Device Sequence Number: 6288185
• Product Code: DQY
• UDI-Device Identifier: 00842429108475
• UDI-Public: (01)00842429108475(11)210907(17)240831(10)0000077529
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150366
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/16/2022

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: 08/31/2024
• Device Model Number: DA6125ST-ASP-US-OD
• Device Lot Number: 0000077529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2022
• Supplement Date Received by Manufacturer: 04/28/2022; 05/27/2022
• Initial Report FDA Received Date: 04/06/2022
• Supplement Report FDA Received Date: 05/27/2022; 06/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2021
• 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