MAUDE Adverse Event Report: COOK INC COOK CHECK-FLO INTRODUCER FLEXOR SHEATH; INTRODUCER, CATHETER

Model Number	G13091
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/14/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Sheath separated at the hub while performing sheath exchange.

• Brand Name: COOK CHECK-FLO INTRODUCER FLEXOR SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC
• MDR Report Key: 8261087
• Report Number: MW5083236
• Device Sequence Number: 11334609
• Product Code: DYB
• UDI-Device Identifier: 00827002130913
• UDI-Public: (01)00827002130913
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 01/12/2021
• Device Model Number: G13091
• Device Catalogue Number: KCFW-5.0-38-70-RB-RAABE
• Device Lot Number: 8507251
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR