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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
Model Number AB35W08040135
Device Problem Burst Container or Vessel (1074)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/18/2019
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 plaque lesion in the patients¿ mid superficial femoral artery (sfa). Slight vessel tortuosity and calcification are reported. Lesion exhibited 60% stenosis. A non-medtronic inflation device was used. No damage noted to packaging prior to use. No issues noted when removing the device from the packaging. Ifu was followed. The device was prepped without issue. The device was not passed through a previously deployed stent. No resistance was encountered when advancing the device. It is reported that a longitudinal balloon burst occurred during balloon inflation at a pressure of 8atm. No balloon fragments were left in the patient. The device was replaced with another medtronic device to complete the procedure. No injury 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 Key9519252
MDR Text Key189989907
Report Number2183870-2019-00600
Device Sequence Number1
Product Code LIT
UDI-Device Identifier00763000184803
UDI-Public00763000184803
Combination Product (y/n)N
Reporter Country CodeCH
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 03/26/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/20/2022
Device Model NumberAB35W08040135
Device Catalogue NumberAB35W08040135
Device Lot NumberA851957
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/19/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/25/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/21/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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