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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 AB35W04040135
Device Problem Burst Container or Vessel (1074)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/21/2022
Event Type  malfunction  
Event Description
Physician used an evercross pta balloon during treatment of a lesion in the patient's distal common iliac artery. Slight vessel tortuosity and clarification are 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. The device was not passed through a previously deployed stent. A syringe was used for balloon inflation. Inflation fluid was used. No resistance was noted during advancement. A balloon burst is reported at 12arm. The balloon did not fragment. The balloon was replaced to complete the procedure. No vessel injury noted. No 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 Key14239047
MDR Text Key293653731
Report Number2183870-2022-00160
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/28/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAB35W04040135
Device Catalogue NumberAB35W04040135
Device Lot NumberB226040
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/21/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/25/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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