MAUDE Adverse Event Report: COOK, INC. CELECT IVC FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 04/18/2019

Event Type  Injury  

Event Description

Celect ivc filter found to have multiple fractures; 1 leg is extravascular in the right psoas muscle, one arm is fractured and retained locally. The filter and intravascular fragment were removed. The extravascular fragment was left in place for now. Fda safety report id# (b)(4).

• Brand Name: CELECT IVC FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK, INC. ; bloomington IN
• MDR Report Key: 8541209
• MDR Text Key: 142957406
• Report Number: MW5086069
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 04/22/2019 Patient Sequence Number: 1