MAUDE Adverse Event Report: ABBOTT AGILIS SHEATH; INTRODUCER, CATHETER

Device Problem Use of Device Problem (1670)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

Event Date 04/14/2023

Event Type  Injury  

Event Description

1.Situation 2 hours after the end of the procedure.Heard about a patient's groin area that wouldn't stop bleeding.At the end of the case, it was difficult to stop the bleeding and patient was sent directly to the ward.Currently trying to stop the bleeding with a sandbag.The patient's thigh was swollen throughout, and may have also pierced an artery when punctured, and a contrast ct was needed.2.Timing 2 hours after the end of the procedure.3.How to complete the procedure the patient?s condition is currently followed up.Version information: v7.2.40.250".The complaint product(s) will not be returned for analysis.Biosense webster inc.Complaint number: (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: AGILIS SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ABBOTT
• MDR Report Key: 17488048
• MDR Text Key: 320687438
• Report Number: MW5120772
• 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: 06/13/2023

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