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U.S. Department of Health and Human Services

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

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COVIDIEN EVERCROSS 035 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA Back to Search Results
Model Number AB35W08040080
Device Problems Burst Container or Vessel (1074); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Patient Problem Insufficient Information (4580)
Event Date 04/06/2022
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician was attempting to use the evercross pta balloon during procedure to treat superficial femoral artery. A 6fr sheath and 0. 035'' guidewire were used. There was no damage noted to packaging, i. E. Shelf carton, hoop/tray and no issues noted when removing the device from the hoop/tray. The device was prepped per ifu with no issues. It was reported that the balloon burst under low pressure 5-6 atm. The balloon was dislocated completely from the shaft. The balloon couldn't be removed from the vessel, so it had to be trapped with a covered stent in the distal iliac artery. Physician stated that 'normally if i see that a balloon is destroyed, the covering is on the balloon, but in this case it was away'. No patient injury.
 
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Brand NameEVERCROSS 035
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
Manufacturer (Section D)
COVIDIEN
4600 nathan lane north
plymouth MN 55442
Manufacturer (Section G)
COVIDIEN
4600 nathan lane north
plymouth MN 55442
Manufacturer Contact
alison sweeney
parkmore business park west
galway 
EI  
091708096
MDR Report Key14071599
MDR Text Key291382274
Report Number2183870-2022-00129
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K082579
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAB35W08040080
Device Catalogue NumberAB35W08040080
Device Lot NumberB282105
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/12/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/15/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 04/11/2022 Patient Sequence Number: 1
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