• 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
Catalog Number AB35W10040135
Device Problem Burst Container or Vessel (1074)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 05/08/2018
Event Type  Injury  
Manufacturer Narrative
Two cine images analysis summary: the evercross dilatation catheter was not received for evaluation. No ancillary devices from the procedure were received for evaluation. Two photographic images of cine images were provided. The first image is of the patient¿s left common femoral vein. The evercross dilatation catheter balloon is inflated within two kissing stents. A support catheter is visible in the right common femoral vein. A guidewire runs through the support catheter and evercross dilatation catheter. The second image is of the patient¿s left common femoral vein. The ancillary devices in the patient¿s right common femoral vein have been removed. An ancillary device is seen at the top of the cine image approaching from the abdominal vein. The evercross dilatation balloon chamber appears to be deflated within the kissing stents. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The physician was using an evercross balloon with a non-medtronic 8f sheath and a 0. 035 non-medtronic guidewire for treatment of a 200 mm, 70% (stenosed) soft tissue clot in the patient¿s mid left common femoral vein. The vessel diameter was reported to be between 16-18 mm. A non-medtronic inflation device was used with isovue and saline 1:3. The device was prepped without issue. The device did pass through a previously deployed stent. No resistance was encountered nor excessive force used when advancing the device to the lesion. It was reported that the balloon burst at a pressure of 9 atms for 10 seconds on first inflation. The balloon fragments were retrieved with cystograspers and non medtronic catheters were placed bilaterally. No patient injury was 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 Key7577667
MDR Text Key110343438
Report Number2183870-2018-00319
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
Report Date 06/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/16/2020
Device Catalogue NumberAB35W10040135
Device Lot NumberA558166
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 Received05/09/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/17/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/07/2018 Patient Sequence Number: 1
-
-