• 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 AMPHIRION DEEP PTA BALLOON CATHETER 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 MEXICO AMPHIRION DEEP PTA BALLOON CATHETER CATHETER, PERCUTANEOUS Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Ischemia (1942); Stenosis (2263)
Event Date 12/12/2018
Event Type  Injury  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

During the index procedure, one nanocross balloon and amphiron deep balloon were used to treat the right anterior tibial artery. Post index procedure, the patient developed right foot ischemia. The event was treated with vascular intervention involving the target limb. The investigator and sponsor assessed the event as not related to the index device, procedure or paclitaxel. The event is continuing.

 
Manufacturer Narrative

The event occurred approximately 5 months post index procedure. The event was also treated with surgical debridement. If information is provided in the future, a supplemental report will be issued.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameAMPHIRION DEEP PTA BALLOON CATHETER
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC MEXICO
av.paseo del cucapah #10510
tijuana
tijuana,bc 22570
MX 22570
Manufacturer (Section G)
MEDTRONIC MEXICO
av.paseo del cucapah #10510
tijuana
tijuana,bc 22570
MX 22570
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key8560288
MDR Text Key143398602
Report Number9612164-2019-01497
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeIT
PMA/PMN NumberK052791
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/10/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/29/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
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 Received05/15/2019
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: 04/29/2019 Patient Sequence Number: 1
-
-