MAUDE Adverse Event Report: COOK MEDICAL 6FR FLEXOR BALKIN UP & OVER SHEATH; VASCULAR CATHETER INTRODUCTION SET

Model Number G32224

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/13/2017

Event Type  malfunction  

Event Description

Sheath got stuck in patient's left groin, was removed safely by physician with no present issues.No patient harm but stayed overnight for observation.

• Brand Name: 6FR FLEXOR BALKIN UP & OVER SHEATH
• Type of Device: VASCULAR CATHETER INTRODUCTION SET
• Manufacturer (Section D): COOK MEDICAL; 1186 montgomery ln; vandergrift PA 15690
• MDR Report Key: 6646208
• MDR Text Key: 77714840
• Report Number: 6646208
• Device Sequence Number: 1
• Product Code: DYB
• 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: Other
• Type of Report: Initial
• Report Date: 06/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/19/2020
• Device Model Number: G32224
• Device Lot Number: 7843460
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/13/2017
• Event Location: Hospital
• Date Report to Manufacturer: 06/13/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 78 YR