MAUDE Adverse Event Report: COOK, INC. CATHETER, INTRAVASCULAR, DIAGNOSTIC

Patient Problem Thrombosis/Thrombus (4440)

Event Type  Injury  

Event Description

It was reported that during a watchman procedure.This pigtail catheter was advanced on the versacross rf wire and the versacross rf wire was removed.Then, a full dose of heparin was given to the patient, and at the same time a thrombus was noticed on the pigtail catheter.Therefore, the physician chose to remove it, flush/clean it, re-inserted it, the fxd curve sheath was aspirated, and then the procedure was completed.The pigtail was where the clot was on.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, INC.
• MDR Report Key: 18715069
• MDR Text Key: 335574483
• Report Number: MW5151729
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/14/2024
• Patient Sequence Number: 1
• Treatment: HEPARIN