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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 SBI080040130
Device Problems Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 07/21/2017
Event Type  Injury  
Manufacturer Narrative
Device evaluation summary: the balloon broke at approximately 1 cm from the proximal balloon welding. The distal part of the balloon was missing. The guidewire lumen underneath the balloon stretched. Signs of proximal marker crimping are still visible. The two markers were missing. The tip was missing. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Angio images provided showed the procedure (guidewire loading, device loading, balloon inflation and device withdrawal). If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician intended to use an admiral xtreme device with a 6fr non-mdt sheath and non-mdt 0. 035 guidewire for treatment of a severely calcified lesion in the mid right common iliac artery with little tortuosity. Embolic protection was not used. An non-mdt inflation device was used with contrast and saline. Ifu was followed and no issues were noted during prep. No excessive force used during insertion it is reported that a longitudinal burst occurred during first inflation at 12 atm. Physician went to 8atm then went up to 12atm when balloon burst. It is reported that both markers came off delivery system. Fragments were removed surgically -vessel opened in order to remove detached balloon and 2 platinum iridium markers that had dislodged off the balloon delivery system removed under guidance of image intensifier. Vessel was closed with sutures. Patient is reported as being alive with injury.
 
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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 22570
MX 22570
Manufacturer (Section G)
MEDTRONIC MEXICO
avenida paseo del cucapah #105
parque industrial el lago
tijuana, b.c.,mx 22570
MX 22570
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key6803576
MDR Text Key101017261
Report Number9612164-2017-01138
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeAS
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,Followup
Report Date 02/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2019
Device Catalogue NumberSBI080040130
Device Lot Number211665337
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/23/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/29/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/25/2016
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: 08/18/2017 Patient Sequence Number: 1
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