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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC INC. / EV3, INC IN.PAT ADMIRAL PACLITAXEL COATED PTA BALLOON CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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MEDTRONIC INC. / EV3, INC IN.PAT ADMIRAL PACLITAXEL COATED PTA BALLOON CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number REF: ADM06004013P
Device Problem Fluid Leak (1250)
Patient Problem Insufficient Information (4580)
Event Date 05/17/2021
Event Type  malfunction  
Event Description
Catheter leaking around the hub where the inflation device connects. Balloon would not hold pressure. Fda safety report id # (b)(4).
 
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Brand NameIN.PAT ADMIRAL PACLITAXEL COATED PTA BALLOON CATHETER
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
MEDTRONIC INC. / EV3, INC
MDR Report Key11855332
MDR Text Key252143287
Report NumberMW5101471
Device Sequence Number1
Product Code LIT
Combination Product (y/n)Y
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 05/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/13/2022
Device Model NumberREF: ADM06004013P
Device Lot Number0009739163
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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