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

Model Number G34505

Device Problem Positioning Failure (1158)

Patient Problem No Information (3190)

Event Date 03/03/2016

Event Type  malfunction  

Event Description

Ivc filter legs wouldn't deploy.

• Brand Name: CELECT
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK INC.; 750 daniel way; bloomington IN 47404
• MDR Report Key: 5716795
• MDR Text Key: 47197314
• Report Number: 5716795
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/27/2018
• Device Model Number: G34505
• Device Catalogue Number: IGTCFS-65-1-UNI-CELECT-PT
• Device Lot Number: E3380312
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/15/2016
• Event Location: Hospital
• Date Report to Manufacturer: 05/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 34 YR