• 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, TRANSLUMINA

  • 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, TRANSLUMINA Back to Search Results
Catalog Number SBI050200130
Device Problems Burst Container or Vessel (1074); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/07/2021
Event Type  malfunction  
Event Description
Physician was attempting to use the admiral xtreme balloon during procedure to treat severely calcified lesion in the proximal right superficial femoral artery (sfa). The vessel had no tortuosity and exhibited 70% stenosis. The artery diameter was 6. 5mm and lesion length was 5mm. Abnormalities related to anatomy included partial necrosis of the right hallux and pallor of the entire foot. The balloon was inflated with a syringe and inflation fluid of fs 0. 9% + contrast was used. There was no damage noted to packaging and no issues noted when removing the device from the hoop/tray. The device was prepped per the ifu with no issues identified. It was reported that there was a balloon burst during 3rd balloon inflation at burst pressure. The balloon did not fragment. No intervention required for removal. The device did pass through a previously deployed stent and resistance was encountered when advancing the device. No vessel damage noted. Device was safely removed from patient. A mounted stent was previously implanted. No patient injury.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician was attempting to use the admiral xtreme balloon during procedure to treat severely calcified lesion in the proximal right superficial femoral artery (sfa). The vessel had no tortuosity and exhibited 70% stenosis. The artery diameter was 6. 5mm and lesion length was 5mm. Abnormalities related to anatomy included partial necrosis of the right hallux and pallor of the entire foot. The balloon was inflated with a syringe and inflation fluid of fs 0. 9% + contrast was used. There was no damage noted to packaging and no issues noted when removing the device from the hoop/tray. The device was prepped per the ifu with no issues identified. It was reported that there was a balloon burst during 3rd balloon inflation at burst pressure. The balloon did not fragment. No intervention required for removal. The device did pass through a previously deployed stent and resistance was encountered when advancing the device. No vessel damage noted. Device was safely removed from patient. A mounted stent was previously implanted. No patient injury.
 
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 OTW
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
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
alison sweeney
parkmore business park west
galway 
EI  
091708096
MDR Report Key13522743
MDR Text Key285534255
Report Number9612164-2022-00606
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K062809
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/25/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberSBI050200130
Device Lot Number219762374
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/07/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/23/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-