MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC FLEXCATH SHEATH; INTRODUCER, CATHETER

Device Problem Use of Device Problem (1670)

Patient Problems Pericardial Effusion (3271); Thrombosis/Thrombus (4440)

Event Date 03/28/2023

Event Type  Injury  

Event Description

It was reported that during an afib case, a thrombus was discovered.The caller reported there were no visible signs on the patient.Caller stated after they went transseptal, they were about to insert the balloon and the ice catheter was pointing right at the sheath and they noticed the clot before it was inserted.Caller stated the clot was in the right atrium attached to the sheath right at the septum.The pericardial effusion was confirmed by ice.Caller reported that no medical intervention was provided but they did aspirate with the sheath as it was being removed to bring that clot with it.The procedure was aborted immediately after the clot was discovered.The patient was reported to be in stable condition.The physician did not mention what they thought may have caused the clot.Caller noted that the patient was heparinized, and the ct was within normal limits.The only catheter in the body at the time was the ice catheter and it is not available to return.The thrombus/clot was only visualized on the medtronic flexcath sheath.Biosense webster complaint number - (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: MEDTRONIC FLEXCATH SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17488450
• MDR Text Key: 320687840
• Report Number: MW5121149
• Device Sequence Number: 1
• Product Code: DYB
• 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: 03/29/2023

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2023
• Patient Sequence Number: 1