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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN RAPIDCROSS CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

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COVIDIEN RAPIDCROSS CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA Back to Search Results
Model Number A14BX020060170
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 12/07/2021
Event Type  malfunction  
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Brand NameRAPIDCROSS
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 Key13440618
Report Number2183870-2022-00040
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130911
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,Company Representative
Reporter Occupation Risk Manager
Type of Report Initial,Followup,Followup
Report Date 04/28/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/03/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberA14BX020060170
Device Catalogue NumberA14BX020060170
Device Lot NumberB214038
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received04/08/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/01/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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