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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN EVERCROSS 035 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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COVIDIEN EVERCROSS 035 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number AB35W06040080
Device Problem Burst Container or Vessel (1074)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 07/04/2017
Event Type  Injury  
Manufacturer Narrative
Evaluation summary: the evercross dilatation catheter was received for evaluation. No ancillary devices or cine images from the procedure were received for evaluation. The evercross dilatation catheter was received in two segments: the proximal segment including the y-manifold and catheter down to the proximal balloon bond, and the distal inner guidewire lumen with radiopaque markers, balloon chamber material, and distal tip. All components of the evercross dilatation catheter were accounted for. The separation face of the proximal segment includes the balloon chamber proximal bond to the catheter. The catheter exhibits a small amount of necking down and tensile stretching. The small segment of balloon material exhibits radial tearing. Approximately 10cm of distal inner guidewire lumen with two radiopaque marker bands, balloon chamber material, and distal tip were received loose within the open labelled pouch. The distal segment was placed in a tub of water to clean and relax the material to allow examination of the balloon chamber material. The proximal end of the distal segment exhibits tensile stretching proximal to the proximal radiopaque marker band. This proximal section exhibits lateral compression most likely from the retrieval process. The distal section material between the two radiopaque marker bands exhibit zones of tensile stretching and lateral compression. The balloon material was able to be unfolded and measured. The balloon material exhibits longitudinal and radial tearing. All of the 6mm by 40mm balloon materials appears to be accounted for. The distal inner guidewire lumen exhibits tensile stretching that has elongated the distance between the two radiopaque markers to approximately 65mm. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Ancillary devices used during the procedure: non-medtronic 5 fr sheath non-medtronic 0. 035 guidewire non-medtronic inflation device additional information: patient developed mild stenosis at the site of surgical closure. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician used an evercross pta balloon device for a fistuloplasty procedure of the arm. Ifu was followed. An inflation device was used for inflation. It was reported that the balloon burst during inflation at a pressure of 11atms. It was reported that the physician tried to remove the balloon, and it sheared off on sheath and snapped. The balloon remained in the vessel. Physician had to perform a cut down to retrieve the balloon fragments. It was reported that vessel injury occurred.
 
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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 Key6758714
MDR Text Key100526897
Report Number2183870-2017-00323
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K082579
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/26/2019
Device Catalogue NumberAB35W06040080
Device Lot NumberA217943
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/19/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/21/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/27/2016
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: 08/01/2017 Patient Sequence Number: 1
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