MAUDE Adverse Event Report: MICROVENTION, INC. SOFIA PLUS; CATHETER, PERCUTANEOUS

Model Number 125 CM/STR

Device Problem Bent (1059)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/15/2016

Event Type  malfunction  

Event Description

During an angiogram and thrombectomy a neurocatheter was used.Following the procedure, it was noted that the tip was extremely bent.This did not cause harm to the patient, and the procedure was completed as planned.Per the hospital, the manufacturer wants to examine the device.

• Brand Name: SOFIA PLUS
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MICROVENTION, INC.; 75 columbia; aliso viejo CA 92656
• MDR Report Key: 6036433
• MDR Text Key: 57732639
• Report Number: 6036433
• Device Sequence Number: 0
• Product Code: DQO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 125 CM/STR
• Device Catalogue Number: DA6125ST
• Device Lot Number: 16010233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2016
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/20/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 09/20/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/18/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 84 YR