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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); Detachment of Device or Device Component (2907)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 09/22/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician attempted to use an evercross pta balloon with a 6fr non-medtronic sheath and a. 035 non-medtronic guidewire during treatment of a severe calcified lesion in the patient¿s mid right proximal common illiac artery. Slight vessel tortuosity is reported. Lesion exhibited cto (chronic total occlusion-100%) stenosis. A non-medtronic inflation device was used for balloon inflation. Contrast/ saline inflation fluid was used. No embolic protection was used. There was no damage noted to packaging, i. E. Shelf carton, hoop/tray. No issues were noted when removing the device from the hoop/tray. Ifu was followed and the device was prepped without issue. No resistance was noted during advancement of the device and no excessive force was used. The device was passed through a previously deployed stent. It was reported that the balloon ruptured and sheared in half just distal to the proximal marker when inflated to 10 atms. It is unknown where the burst occurred. 2 prior inflations had been applied in the vessel and the rupture occurred during post dilation of the stent. The balloon fragmented. No resistance was noted when removing the device from the patient. The fragmented b alloon portion was left in the patient. No damage was noted to the vessel. An attempt to snare the balloon portion was made but was unsuccessful. Another stent which was needed anyways was used to trap balloon portion against vessel wall to let it endothelialize. No patient 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 Key12532082
MDR Text Key273319261
Report Number2183870-2021-00354
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 11/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/12/2022
Device Model NumberAB35W06200135
Device Catalogue NumberAB35W06200135
Device Lot NumberA863540
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/26/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/05/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/13/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 09/27/2021 Patient Sequence Number: 1
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