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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 AB35W06030135
Device Problem Burst Container or Vessel (1074)
Patient Problem Myocardial Infarction (1969)
Event Date 09/02/2021
Event Type  Death  
Manufacturer Narrative
Date of death is month and year valid. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician attempted to use an evercross pta balloon during treatment of a calcified lesion in the patient's left common iliac artery. Severe vessel calcification is reported. 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. The device was prepped as per ifu without issue. Inflation device was used for balloon inflation. A balloon burst is reported. The device had to be surgically removed from the patient's artery. The patient is now deceased, the patient had a myocardial infarction days after the case.
 
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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 Key12726450
MDR Text Key279226306
Report Number2183870-2021-00396
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,Followup
Report Date 12/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAB35W06030135
Device Catalogue NumberAB35W06030135
Device Lot NumberB006908
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/25/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/17/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/10/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 11/01/2021 Patient Sequence Number: 1
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