MAUDE Adverse Event Report: COOK MEDICAL CELECT; FILTER

Model Number IGTCFS-65-UNI-CELECT

Device Problem Split (2537)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2014

Event Type  malfunction  

Event Description

The inner dilator of the sheath split apart after completing a power injection at 450 psi.There was no pt injury.

• Brand Name: CELECT
• Type of Device: FILTER
• Manufacturer (Section D): COOK MEDICAL; bloomington IN 47402
• MDR Report Key: 3698119
• MDR Text Key: 4270018
• Report Number: MW5035189
• Device Sequence Number: 1
• Product Code: DTK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IGTCFS-65-UNI-CELECT
• Device Catalogue Number: G52915
• Device Lot Number: E3141912
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR