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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN EVERCROSS CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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COVIDIEN EVERCROSS CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number AB35W06040080
Device Problems Degraded (1153); Material Rupture (1546)
Patient Problem Stenosis (2263)
Event Date 02/24/2020
Event Type  malfunction  
Event Description
During a right upper extremity hd graft de-clot with central venogram and selective right pulmonary arteriography, high grade arterial stenosis was noted after de-clotting. A 6mm ev3 angioplasty balloon was deployed. During inflation of the balloon, the procedure became complicated due to patient movement. Radiologist reported having to grab the right upper extremity to keep the patient on the table. It was noted that the angioplasty balloon ruptured around the time of patient movement.
 
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Brand NameEVERCROSS
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
COVIDIEN
4600 nathan lane north
plymouth MN 55442
MDR Report Key9817369
MDR Text Key182940139
Report Number9817369
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 03/05/2020,03/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/11/2020
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAB35W06040080
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/05/2020
Event Location No Information
Date Report to Manufacturer03/11/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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