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U.S. Department of Health and Human Services

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

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MEDTRONIC MEXICO ADMIRAL XTREME OTW CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number SBI070040130
Device Problem Device Expiration Issue (1216)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 03/27/2017
Event Type  Injury  
Event Description
Physician used admiral xtreme to treat a calcified lesion in the sfa. Procedure was completed successfully. It was reported that the device was used approximately 1 month post expiry. The patient was placed on antibiotics. No further sequelae reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NameADMIRAL XTREME OTW
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 Key6517818
MDR Text Key73557384
Report Number9612164-2017-00492
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K062809
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 03/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2017
Device Catalogue NumberSBI070040130
Device Lot Number207996340
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 Received03/28/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/05/2014
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: 04/25/2017 Patient Sequence Number: 1
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