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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 SBI090040130
Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Material Deformation (2976)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 07/29/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician used an admiral xtreme with a 6fr introducer sheath and 0. 035 x 260cm aqwire guidewire during treatment of a stenotic lesion in the patient¿s subclavian vein. Lesion was 1cm in length and exhibited 60% stenosis. No calcification present in vessel. Vessel described as being excessively tortuous with more than 3 bends. During the procedure, following inflation, it is reported the balloon deformed and could not be retrieved through the introducer sheath. While maneuvering to retrieve the balloon from the vasculature, it is reported the balloon broke into pieces. The balloon fragments were retrieved with a snare device.
 
Manufacturer Narrative
Additional information: the device was passed through a previously deployed stent. A non-medtronic inflation device was used to inflate the balloon within ifu recommendations. A balloon burst occurred. All fragments removed from the patient. 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 Key8873279
MDR Text Key153659479
Report Number9612164-2019-03276
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeCY
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 08/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2021
Device Catalogue NumberSBI090040130
Device Lot Number215543368
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 Received08/28/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/28/2018
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: 08/08/2019 Patient Sequence Number: 1
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