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

MAUDE Adverse Event Report: COVIDIEN EVERCROSS 035 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
 

COVIDIEN EVERCROSS 035 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number AB35W05080135
Device Problems Burst Container or Vessel (1074); Positioning Problem (3009)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician intended to use an evercross pta balloon during treatment of a calcified and plaque lesion in the patient¿s distal common iliac artery and superficial femoral artery. Vessel diameter is reported as 6mm. Lesion exhibited 70% stenosis. Severe vessel calcification and tortuosity are reported. 3 evercross pta balloons are reported to have been used. No damage was noted to the packaging of any of the devices, and no issues were noted during removal from the product packaging. Ifu was followed and the 3 balloons were prepped without issue. A non-medtronic inflation device is reported to have been used for balloon inflation. Embolic protection was not used during the procedure. For the first evercross balloon, it is reported that no resistance was encountered during advancement and the device was not passed through a previously deployed stent. A circumferential/radial balloon burst is reported during balloon inflation at a pressure of 15atm (above rbp). 4 prior inflations had been applied to the device. The device was replaced. For the second evercross pta balloon, it is reported that resistance was encountered during advancement and the device was not passed through a previously deployed stent. A circumferential/radial balloon burst at 15atm is reported for the second evercross balloon also, with 4 inflations having been previously applied. The balloon was replaced with a third evercross pta balloon. A circumferential/radial balloon burst at 16atm is reported for the third balloon during inflation. The device was replaced with a bigger balloon to complete the procedure. In all cases, no balloon fragments were left in the patient. It was also reported the 3 balloons failed to cross the lesion. No patient injury reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameEVERCROSS 035
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
COVIDIEN
4600 nathan lane north
plymouth MN 55442
Manufacturer (Section G)
COVIDIEN
4600 nathan lane north
plymouth MN 55442
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key10611676
MDR Text Key209357281
Report Number2183870-2020-00313
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082579
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/02/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAB35W05080135
Device Catalogue NumberAB35W05080135
Device Lot NumberB054148
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 Received12/01/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/15/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-