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

MAUDE Adverse Event Report: MEDTRONIC IRELAND AMPHIRION DEEP OTW CATHETER, PERCUTANEOUS

  • 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 IRELAND AMPHIRION DEEP OTW CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number AMD025080152
Device Problems Deflation Problem (1149); Inflation Problem (1310)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/16/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician was attempting to use amphirion deep pta balloon catheter during procedure to treat a little calcified plaque lesion in the mid posterior tibial artery (pta) and peroneal artery with 50% stenosis. The vessel was moderately tortuous. The vessel diameter and lesion length are 2. 5mm and 75mm respectively. A non-medtronic indeflator was used for balloon inflation. There was no damage noted to packaging. There was no issue noted when removing device from hoop/tray. The device was prepped per ifu with no issues identified. Balloon inflation difficulties was observed at 7bar. The device would then not deflate at the lesion site. The device did not pass through a previously deployed stent. No resistance was encountered when advancing the device. A pressure pump was used to deflate the balloon. The procedure was completed after withdrawing the faulty balloon, replaced with medtronic balloon of same size and model. There was no patient injury.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameAMPHIRION DEEP OTW
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
EI
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
EI
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
EI  
091708734
MDR Report Key12073971
MDR Text Key258611895
Report Number9612164-2021-02494
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K052791
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 07/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberAMD025080152
Device Lot Number221069022
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/05/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/27/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/28/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-