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

Model Number DA5125ST

Device Problems Defective Device (2588); Material Twisted/Bent (2981); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 12/13/2019

Event Type  malfunction  

Event Description

As the provider opened the catheter packaging for use, he noted that the catheter was bent and not usable.The catheter was not used on 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: 9557352
• MDR Text Key: 173923687
• Report Number: 9557352
• 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: 12/30/2019,12/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2020
• 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: 190903138
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/30/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 19345 DA
• Patient Weight: 106