MAUDE Adverse Event Report: COOK CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number CHECK-FLO 18FR

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

During the implant of a transcatheter bioprosthetic valve, the non medtronic sheath caused an intimal injury as there was substantial force applied due to resistance when advancing.Subsequently, a stent was placed.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK
• MDR Report Key: 17530224
• MDR Text Key: 321037951
• Report Number: MW5137145
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: CHECK-FLO 18FR
• Patient Sequence Number: 1