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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC VASCULAR EVERCROSS DILATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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MEDTRONIC VASCULAR EVERCROSS DILATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number AB35W05040080
Device Problem Material Puncture/Hole (1504)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/10/2020
Event Type  malfunction  
Event Description
The balloon catheter used for angioplasty was found with hole in it as the surgeon tries to draw it out from the patient. No harm reached the patient. A new balloon catheter of the same size was opened and used. Fda safety report id# (b)(4).
 
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Brand NameEVERCROSS DILATION CATHETER
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
MEDTRONIC VASCULAR
MDR Report Key10430898
MDR Text Key203829817
Report NumberMW5096145
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 08/17/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberAB35W05040080
Device Lot NumberB025146
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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