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

Model Number DA5125ST

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 09/07/2021

Event Type  malfunction  

Event Description

During preparation the md was unable to pass the wire through the sofia distal access catheter.The catheter was removed and replaced without harm to the patient.

• Brand Name: SOFIA 5F-125CM STR
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MICROVENTION INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 12540391
• MDR Text Key: 273650429
• Report Number: 12540391
• 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
• Type of Report: Initial
• Report Date: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DA5125ST
• Device Catalogue Number: DA5125ST
• Device Lot Number: 21031953A
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/17/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1