MAUDE Adverse Event Report: SOFIA DISTAL ACCESS CATHETER; PERCUTANEOUS CATHETER

Model Number	DA5125ST
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Telephone number: (b)(6).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.Investigation is ongoing.
Event or Problem Description
It was reported that during the procedure patient developed an occlusion of the basilar artery.When the solitaire retriever was pulled back, the physician felt some resistance.After the retriever was pulled out, the braiding of the sofia catheter was extracted together with the retriever.
Additional Manufacturer Narrative
The reported complaint is confirmed.The damaged liner and coil indicate that the device experienced forces over specification.The sofia ifu advises the user to ".Not advance or withdraw the device when excessive resistance is met until the cause of resistance is determined.".

• Brand Name: SOFIA DISTAL ACCESS CATHETER
• Common Device Name: PERCUTANEOUS CATHETER
• MDR Report Key: 11816613
• Report Number: 2032493-2021-00201
• Device Sequence Number: 3686251
• Product Code: DQO
• UDI-Device Identifier: 00810170019234
• UDI-Public: (01)00810170019234(11)200904(17)230831(10)20090452Y
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K131482
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2021

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: 08/31/2023
• Device Model Number: DA5125ST
• Device Catalogue Number: DA5125ST
• Device Lot Number: 20090452Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 05/25/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2020
• 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 Age: 68 YR