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U.S. Department of Health and Human Services

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

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MEDTRONIC MEXICO ADMIRAL XTREME CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Perforation of Vessels (2135); Stenosis (2263); Vascular Dissection (3160)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic conducted a post market clinical follow-up (pmcf) survey to seek out potential new risks and assess the performance of medtronic¿s admiral xtreme pta balloon catheter. Survey results received for an interventional cardiologist with 21 years¿ experience who was been using the admiral xtreme pta balloon catheter since 2019. The respondent used 350 admiral xtreme devices since practicing, and 300 admiral xtreme in the last 12 months. During use of the admiral xtreme pta balloon catheter, it was reported that the respondent experienced 8 dissection in the dilated artery wall events or complications associated with dilatation which were deemed somewhat concerning and related to device, and 2 perforation of the artery wall deemed very concerning and related to device.
 
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Brand NameADMIRAL XTREME
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
MEDTRONIC MEXICO
av. paseo del cucapah #10510
tijuana,bc 22570
MX 22570
Manufacturer (Section G)
MEDTRONIC MEXICO
av. paseo del cucapah #10510
tijuana,bc 22570
MX 22570
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key9749432
MDR Text Key188805750
Report Number9612164-2020-00856
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K173515
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/14/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received05/11/2020
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

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