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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND ADMIRAL XTREME CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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MEDTRONIC IRELAND ADMIRAL XTREME CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number UNK-CV-GWY-ADM
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Aneurysm (1708); Patient Problem/Medical Problem (2688)
Event Date 05/10/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
During the index procedure one medtronic standard pta device was used to treat a lesion located in the venous outflow of the left arm. Approximately 2 months post index procedure, patient suffered an aneurysm in the area of the fistula. Event was treated with a surgical intervention of the venous outflow. Investigator assessed that the event is not related to index device, procedure or antiplatelets medication. Outcome of the event is unknown.
 
Manufacturer Narrative
Patient has a history of hypertension, renal insufficiency, coronary heart disease and previous peripheral revascularization of the in cannulation zone and venous outflow. Event was treated with pta of venous outflow. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Ae term updated to "avf aneurysm" and patient recovered. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
It was confirmed that the index device was not a medtronic pta. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
A medtronic standard pta device was during the index procedure. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameADMIRAL XTREME
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key7609375
MDR Text Key111318796
Report Number9612164-2018-01466
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K062809
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 11/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK-CV-GWY-ADM
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/16/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/18/2018 Patient Sequence Number: 1
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