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

Model Number DA5125ST

Device Problems Obstruction of Flow (2423); Device Damaged by Another Device (2915)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/08/2021

Event Type  malfunction  

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 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.

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
• Type of Device: PERCUTANEOUS CATHETER
• MDR Report Key: 11816613
• MDR Text Key: 256277688
• Report Number: 2032493-2021-00201
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00810170019234
• UDI-Public: (01)00810170019234(11)200904(17)230831(10)20090452Y
• Combination Product (y/n): N
• PMA/PMN Number: K131482
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 04/12/2021
• Initial Date FDA Received: 05/13/2021
• Supplement Dates Manufacturer Received: 04/26/2021
• Supplement Dates FDA Received: 05/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR