• 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 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 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Occlusion (1984); Vascular Dissection (3160)
Event Date 08/26/2017
Event Type  Injury  
Manufacturer Narrative
Event date is literature article published date percutaneous intervention for restoration of patency of occluded lower limb arteriovenous dialysis access indian heart journal (2017) vol. 70 issue 3 pg 450-454 10. 1016/j. Ihj. 2017. 08. 015. If information is provided in the future, a supplemental report will be issued.
 
Event Description
This article reports on a (b)(6) female with ckd (chronic kidney disease) on maintenance dialysis twice weekly with uremic symptoms from the past 3 days. She had a saphenofemoral loop av fistula on the right lower limb. Left femoral arterial access was taken and 7 f arterial sheath (non-mdt) was inserted. Fistulography was done with 6f right catheter (non-mdt) after crossing over to the right superficial femoral artery. It showed complete occlusion of the venous outflow with normal arterial inflow segment. The fistula was hooked with 3. 5 f right (non-mdt) catheter and 0. 35 inch (non-mdt) j tipped wire was used to cross the obstruction. It was exchanged with 0. 35-inch stiff wire (non-mdt) with the help of a non-mdt infusion catheter. The entire venous loop with the obstruction was sequentially dilated with 5 20 mm non-mdt balloon and 6 x 60 mm admiral balloon (medtronic-invatec) at 20 to 22 atm. Post procedure angiogram showed good opening of the proximal saphenous venous loop with good distal outflow. Immediate complication observed was extravasation of dye to subcutaneous tissues during manipulation of the guide wire however, the fistula was crossed successfully and dilated with balloons. Post balloon dilations venograms showed a spontaneous cessation of the dye extravasation, which precluded any further intervention to stop bleeding. At 6th month follow-up, the patient continued to have maintenance hemodialysis through the lower limb saphenofemoral fistula. The patient presented with delayed complication, namely re-occlusion at 9th month with subsequent failure to undergo dialysis. She was taken up for repeat intervention which failed possibly due to localized tear/dissection while negotiating the guidewire through the occluded segment.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameADMIRAL XTREME
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
MEDTRONIC MEXICO
avenida paseo del cucapah #105
parque industrial el lago
tijuana,bc 22570
MX 22570
Manufacturer (Section G)
MEDTRONIC MEXICO
avenida paseo del cucapah #105
parque industrial el lago
tijuana,bc 22570
MX 22570
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key7741766
MDR Text Key115764707
Report Number9612164-2018-01925
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K062809
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received08/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
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: 08/02/2018 Patient Sequence Number: 1
-
-