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U.S. Department of Health and Human Services

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

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MEDTRONIC MEXICO ADMIRAL XTREME US CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number ADM070080130
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Muscle Spasm(s) (1966); Patient Problem/Medical Problem (2688)
Event Date 10/24/2017
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
During the index procedure, a medtronic balloon was used to treat a lesion in the right cephalic arch. On the same day, vessel spasm occurred in the mid cephalic vein after treatment of target lesion requiring ballooning. The investigator assessed the event as casually related to the index device, procedure and antiplatelet medication. The patient recovered.
 
Manufacturer Narrative
Cec adjudicated that the event is related to procedure but not related to therapy or device. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The investigator assessed the event as not related to the therapy. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Product id provided. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameADMIRAL XTREME US
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 Key7909039
MDR Text Key121704286
Report Number9612164-2018-02529
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
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,Followup,Followup
Report Date 07/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberADM070080130
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 Received06/28/2019
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: 09/26/2018 Patient Sequence Number: 1
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