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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 AB35W05040135
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/10/2021
Event Type  malfunction  
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 during treatment of a calcified lesion in the patient's mid superficial femoral artery (sfa). Slight vessel calcification is reported. Lesion exhibited 80% stenosis. 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. Device prepped as per ifu without issue. The device was not passed through a previously deployed stent. No resistance was noted during advancement and no excessive force was used. The balloon was found to be leaking during use and cannot be used multiple times. The device was replaced to complete the procedure. 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 Key12802046
MDR Text Key282207855
Report Number2183870-2021-00418
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K082579
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/04/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAB35W05040135
Device Catalogue NumberAB35W05040135
Device Lot NumberB184932
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/03/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/03/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/02/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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