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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 AB35W06200135
Device Problem Burst Container or Vessel (1074)
Patient Problem Perforation (2001)
Event Date 08/19/2021
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 an evercross pta balloon along with a 6fr sheath during procedure to treat a moderately calcified lesion in the mid superficial femoral artery (sfa). The vessel was moderately tortuous. An inflation device was used for balloon inflation. There was no damage noted to packaging. There was no issue noted when removing the device from hoop/tray. The device was prepped per ifu with no issues identified. The device did not pass through a previously deployed stent. There was no resistance encountered when advancing the device. It was reported that during balloon inflation, balloon burst occurred at 11atm (rbp). 1 prior inflation was applied to the device for 40 seconds prior to the issue occurring. Physician snared the balloon after two attempts. It is reported aortic injury occurred while snaring the balloon material that ruptured. Vessel perforation is reported. Physician carried out aaa repairs with covered stent damaged aorta which was caused while retrieving the pta material that broke off. All fragments of the balloon were retrieved. 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
toni o'doherty
parkmore business park west
galway 
EI  
091708734
MDR Report Key12357948
MDR Text Key267811809
Report Number2183870-2021-00306
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAB35W06200135
Device Catalogue NumberAB35W06200135
Device Lot NumberB187050
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/27/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/28/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/07/2021
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: 08/24/2021 Patient Sequence Number: 1
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