MAUDE Adverse Event Report: ABBOTT MEDICAL HEMOSTASIS INTRODUCER ULTIMUM 6ACT F 23CM; INTRODUCER, CATHETER

Device Problem Entrapment of Device (1212)

Patient Problems Laceration(s) (1946); Pain (1994); Obstruction/Occlusion (2422); Foreign Body In Patient (2687); Foreign Body Embolism (4439)

Event Date 07/05/2022

Event Type  Injury  

Event Description

The patient is a [redacted] age man who has a past medical history significant for htn, hld, cad, cabg, pvd with claudication with a history of multiple procedures conducted via the right common femoral artery (cfa).On [date redacted], the patient underwent a transfemoral aortic valve replacement (tavr) procedure in main or.A perclose was used on the left cfa and angioseals were used on the left and right cfa puncture sites.On [dated redacted], the patient presented to the vascular surgery clinic with complaints of disabling right leg claudication.Ct angiogram showed a right iliac lesion and a near occlusion of the right common femoral artery.The patient underwent a right femoral endarterectomy with retrograde iliac stenting on [date redacted].During incision, two foreign bodies were noted in the right cfa causing an obstruction.The pieces were removed and passed off to the back table.The remainder of the procedure was uneventful.

• Brand Name: HEMOSTASIS INTRODUCER ULTIMUM 6ACT F 23CM
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 16193941
• MDR Text Key: 307571298
• Report Number: 16193941
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/03/2023

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?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/03/2023
• Event Location: Hospital
• Date Report to Manufacturer: 01/18/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/18/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 24455 DA
• Patient Sex: Male