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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 SBI050120130
Device Problem Material Fragmentation (1261)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/14/2018
Event Type  Injury  
Manufacturer Narrative
Evaluation summary: the device was returned for evaluation. A visual and tactile inspection was carried out on the device with the following results: the balloon was detached and the guidewire lumen underneath the balloon was stretched. No further test could be performed based on the device conditions. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the physician intended to use an admiral xtreme for treatment of a severely calcified/plaque/fibrous lesion in the patients mid superficial femoral artery(sfa)/popliteal artery(fa). The vessel was reported to be moderately tortuous. The lesion exhibited 80% stenosis. The device was prepped without any issues. No embolic protection was used. The device was passed through a previously deployed stent without any resistance encountered. The balloon was inflated using an inflation device. It was reported that the balloon burst at a pressure of 8bar. It is unknown how many previous inflations were applied to the balloon. Following this, removal difficulties were experienced. No excessive force was used. The endoluminal angiography showed that there were two fragments of balloon in the blood vessel. A capture device was used to remove the material and complete the procedure. No patient injury was reported.
 
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Brand NameADMIRAL XTREME OTW
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
MEDTRONIC MEXICO
avenida paseo del cucapah
parque industrial el lago
tijuana,bc 22570
MX 22570
Manufacturer (Section G)
MEDTRONIC MEXICO
avenida paseo del cucapah
parque industrial el lago
tijuana,bc 22570
MX 22570
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key7536180
MDR Text Key108977120
Report Number9612164-2018-01196
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeCH
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
Report Date 05/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/20/2020
Device Catalogue NumberSBI050120130
Device Lot Number214054593
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/08/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/25/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/20/2017
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: 05/23/2018 Patient Sequence Number: 1
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