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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 AB35W07200135
Device Problem Burst Container or Vessel (1074)
Patient Problems Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)
Event Date 04/20/2022
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
A physician attempted to use an evercross pta balloon during treatment of a calcified cto (chronic total occlusion-100%) in the patient's proximal common iliac artery. Moderate vessel tortuosity and severe calcification are reported. A non-medtronic inflation device was used for balloon inflation. There was no damage noted to packaging, i. E. Shelf carton, hoop/tray.  there were no issues noted when removing the device from the hoop/tray. The device was prepped as per ifu without issue. The device was not passed through a previously deployed stent. Resistance is reported during advancement of the device. A circumferential/radial balloon burst is reported during inflation at 12 atm. Not all balloon fragments were removed from the patient.  a 7x120 entrust everflex stent was used to stent the balloon material in the arterial wall and post dilated with a 7x150 pta balloons. No further injury reported.
 
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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 Key14239097
MDR Text Key290307812
Report Number2183870-2022-00159
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAB35W07200135
Device Catalogue NumberAB35W07200135
Device Lot NumberB333806
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/20/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/05/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 04/28/2022 Patient Sequence Number: 1
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