MAUDE Adverse Event Report: COOK INCORPORATED COOK FLEXOR CHECKFLO VASCULAR CATHETER; INTRODUCER, CATHETER

Model Number MFR# G29981

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/14/2021

Event Type  malfunction  

Event Description

Catheter broke intra-arterially and necessitated additional procedure to remove broken piece of device.Fda safety report id # (b)(4).

• Brand Name: COOK FLEXOR CHECKFLO VASCULAR CATHETER
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INCORPORATED
• MDR Report Key: 11869865
• MDR Text Key: 252693336
• Report Number: MW5101489
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): Y
• 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: 05/19/2021

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
• Device Operator: No Information
• Device Model Number: MFR# G29981
• Device Lot Number: KCFW-%.0-18/38-45-RB-ANL1-HC
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/21/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1