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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CREAGH MEDICAL SUBLIME RADIAL ACCESS 018 RXPTA DILATATION CATHETER PERIPHERAL ANGIOPLASTY BALLOON CATHETER

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CREAGH MEDICAL SUBLIME RADIAL ACCESS 018 RXPTA DILATATION CATHETER PERIPHERAL ANGIOPLASTY BALLOON CATHETER Back to Search Results
Model Number SRA-DC18-60150
Device Problems Structural Problem (2506); Sharp Edges (4013)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/09/2022
Event Type  malfunction  
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Brand NameSUBLIME RADIAL ACCESS 018 RXPTA DILATATION CATHETER
Type of DevicePERIPHERAL ANGIOPLASTY BALLOON CATHETER
Manufacturer (Section D)
CREAGH MEDICAL
ida business park
creagh road
ballinasloe, co. galway, ireland
EI
Manufacturer (Section G)
CREAGH MEDICAL
ida business park
creagh road
ballinasloe, co. galway, ireland
EI
Manufacturer Contact
holly ramirez
7905 golden triangle drive
eden prairie, MN 55344
MDR Report Key13980713
Report Number3014687026-2022-00003
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K211044
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 03/14/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSRA-DC18-60150
Device Lot Number22101971
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received03/09/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/19/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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