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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 Problems Burst Container or Vessel (1074); Deflation Problem (1149); Difficult to Remove (1528)
Patient Problems Obstruction/Occlusion (2422); Embolism/Embolus (4438); Thrombosis/Thrombus (4440)
Event Date 03/26/2022
Event Type  Injury  
Event Description
Physician was attempting to use an evercross pta balloon along with non-medtronic 7fr sheath and 0. 035" stiff wire during procedure to treat a moderately calcified plaque lesion in the left distal common iliac artery. The vessel is moderately tortuous. The vessel diameter and lesion length are 7mm and 250mm respectively. There was no embolic protection used. A non-medtronic inflation device used. A 1/2 nss and 1/2contrast used for inflation fluid. There was no damage noted to packaging. There was no issue noted when removing the device from the hoop/tray. The device was prepped per ifu with no issues identified. It was reported that during balloon inflation, balloon burst occurred at 8atm on first inflation. All fragments of the balloon were retrieved. Removal difficulties occurred with difficulty removing balloon following balloon inflation. The device did not pass through a previously deployed stent. There was no resistance encountered when advancing the device. It was reported that balloon was pulled with force through the sheath after rupture. It was extremely difficult to remove due to balloon rupturing and not completely deflating. Physician reported embolism and thrombus were complications associated with this event. Vessel occlusion also occurred due to the thrombus. No further patient injury reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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 Key14110061
MDR Text Key289274252
Report Number2183870-2022-00136
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,Followup
Report Date 04/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAB35W06200135
Device Catalogue NumberAB35W06200135
Device Lot NumberB335537
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/14/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/08/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 04/14/2022 Patient Sequence Number: 1
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