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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 AB35W09040080
Device Problems Burst Container or Vessel (1074); Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/23/2018
Event Type  malfunction  
Manufacturer Narrative
The evercross device was returned for evaluation. No ancillary devices were included. A visual inspection was completed. The evercross balloon was in a post inflated state and dried blood and a clear crystalized substance (likely contrast) was observed within the balloon. No longitudinal tear was observed. Functional testing was performed. A 10ml syringe filled with water was connected to the balloon port and the plunger was pressed. The balloon inflated, but a spray of water was coming from the proximal end of the balloon. The spray of water was coming out approximately 5cm from the distal end of the catheter. Bubbling was observed from the area were the water was spraying out from. Under microscope a pinhole was identified. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The physician was attempting to use a evercross with a 6fr non-medtronic sheath and a non-medtronic 0. 035" glidewire to treat a 25mm fibrous lesion with 75% stenosis in the mid aterial/venous graft of diameter 9mm. The ifu was followed and the device was prepped without issue. The balloon was inflated using a non-medtronic inflation device with a 50/50 mixture of contrast and normal saline. It was reported that the balloon was inflated to 11 atm and ruptured. It appears that it was a longitudinal crack. All of the balloon was removed from the patient and none was left behind in the patient. The procedure was completed using a fortrex balloon, of the same size, without further issue. No patient injury was reported.
 
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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 Key7892980
MDR Text Key120830429
Report Number2183870-2018-00446
Device Sequence Number1
Product Code LIT
UDI-Device Identifier00821684062159
UDI-Public00821684062159
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 09/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/27/2020
Device Catalogue NumberAB35W09040080
Device Lot NumberA561883
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/04/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/23/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/28/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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