• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC MEXICO ADMIRAL XTREME OTW CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number SBI080060130
Device Problems Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 07/28/2017
Event Type  Injury  
Manufacturer Narrative
A non-medtronic 0. 35 guidewire was used. And a mixture of 5 cc of contrast solution to 10 cc of water was used to inflate the balloons. It was reported that on the second slow inflation, the balloon burst. The balloon burst at 15 bar and the two inflations took approx 30 seconds. The balloon ruptured and approx half of the balloon was detached and migrated from the sanguineous torrent to the lung. 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
The physician was attempting to use one admiral xtreme to treat a common iliac artery exhibiting plaque. No abnormalities were reported in relation to anatomy. The device was removed from its packaging and inspected with no issues noted. Embolic protection was not used. The device was prepped per the ifu. The device did not pass through a previously deployed stent. No resistance was encountered when advancing the device and no excessive force was used. It was reported that on inflation the balloon burst. The balloon ruptured and approx half of the balloon was detached and migrated from the arm to the lung. After several attempts, the balloon fragment was removed using a stopping loop. The physician used another non-mdt device to complete the procedure.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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.,bc 22570
MX 22570
Manufacturer (Section G)
MEDTRONIC MEXICO
avenida paseo del cucapah #105
parque industrial el lago
tijuana, b.c.,bc 22570
MX 22570
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key6838304
MDR Text Key101020451
Report Number9612164-2017-01206
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K062809
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/01/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2019
Device Catalogue NumberSBI080060130
Device Lot Number212025867
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 Received09/08/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/03/2016
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: 09/01/2017 Patient Sequence Number: 1
-
-