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U.S. Department of Health and Human Services

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

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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 Back to Search Results
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).
 
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Brand NameCOVIDIEN EV3 RAPID CROSS 2.50-2.00MM X 20MM X 170CM P+A RAPID EXC BALLOON DILATA
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
MEDTRONIC / COVIDIEN LLC
MDR Report Key13026044
MDR Text Key282584326
Report NumberMW5106137
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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
Date FDA Received12/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberA14BX025210170
Device Catalogue NumberA14BX025210170
Device Lot NumberB278274
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/16/2021 Patient Sequence Number: 1
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