MAUDE Adverse Event Report: MEDTRONIC / COVIDIEN LLC COVIDIEN EV3 RAPID CROSS 2.50-2.00MM X 20MM X 170CM P+A RAPID EXC BALLOON DILATA; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number A14BX025210170

Device Problem Material Fragmentation (1261)

Patient Problems Laceration(s) (1946); Foreign Body In Patient (2687)

Event Date 11/24/2021

Event Type  Injury  

Event Description

Successful atherectomy and opening of the superficial femoral artery and popliteal artery occlusions (under general anesthesia).However, a balloon catheter fracture and fragmentation resulted in retained foreign object that could not be removed and necessitated surgical intervention.Multiple attempts to remove the fractured and retained fragment were performed using multiple wires and snare catheters.After review of images and discussion it was elected the patient to be taken to the operating room to undergo removal of the catheter fragment as well as repair of the common femoral artery stenosis and consideration of possible distal bypass.Added procedure included: removal of retained balloon catheter (fracture) from left popliteal artery, left common femoral endarterectomy with patch.Fda safety report id # (b)(4).

• Brand Name: COVIDIEN EV3 RAPID CROSS 2.50-2.00MM X 20MM X 170CM P+A RAPID EXC BALLOON DILATA
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): MEDTRONIC / COVIDIEN LLC
• MDR Report Key: 13026044
• MDR Text Key: 282584326
• Report Number: MW5106137
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00763000110871
• UDI-Public: (01)00763000110871(17)241007(10)
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/15/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: A14BX025210170
• Device Catalogue Number: A14BX025210170
• Device Lot Number: B278274
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White