MAUDE Adverse Event Report: MICROVENTION INC. SOFIA 5F-125CM STR; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number DA5125ST

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/27/2022

Event Type  malfunction  

Event Description

Case was a diagnostic cerebral angiogram, during the case a sofia distal access catheter was used, it was noticed that the tip of the catheter had come off of the catheter and was in the patient's head.The catheter was removed from the field and the microvention representative took the catheter before i was aware of what was going on.The patient was admitted to the icu postop, platelets given.Microvention terumo 5f sofia distal access catheter 125cm/str.

• Brand Name: SOFIA 5F-125CM STR
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MICROVENTION INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 15814266
• MDR Text Key: 303810954
• Report Number: 15814266
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DA5125ST
• Device Catalogue Number: DA5125ST
• Device Lot Number: 0000259890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/08/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/17/2022
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1