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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 SBI070040080
Device Problem Burst Container or Vessel (1074)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/18/2015
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

The physician was attempting to treat a lesion in the left mid sfa using admiral xtreme dilatation balloon catheter. The lesion was calcified and exhibited >70% stenosis, vessel had little tortuosity. It was reported that while inflating the balloon, it only partially inflated and then burst at 6atm. Another admiral xtreme device was used and it was reported that it partially inflated and then burst. The procedure was completed using another admiral xtreme device. No patient injury or other clinical sequelae reported for this event.

 
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Brand NameADMIRAL XTREME OTW
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
MEDTRONIC MEXICO
avenida paseo del cucapah #105
parque industrial el lago
tijuana, b.c.,mx
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key5297059
MDR Text Key34144975
Report Number9612164-2015-01873
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeSZ
PMA/PMN NumberK062809
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 12/01/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/15/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2018
Device Catalogue NumberSBI070040080
Device LOT Number209407009
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 Received12/01/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured03/31/2015
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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