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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CREAGH MEDICAL LTD. DYNAMIS AV ELM PTA BALLOON DILATATION CATHETER

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CREAGH MEDICAL LTD. DYNAMIS AV ELM PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number D1404081675
Device Problem Difficult to Open or Close (2921)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
During procedure the balloon did not deflate/ refold correctly. There was difficulty in retrieval and guide catheter tip was damaged. No complications occured.
 
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Brand NameDYNAMIS AV
Type of DeviceELM PTA BALLOON DILATATION CATHETER
Manufacturer (Section D)
CREAGH MEDICAL LTD.
ida business park
balinasloe, co. galway, galway H53 K 8P4
EI H53 K8P4
Manufacturer (Section G)
CREAGH MEDICAL LTD.
ida business park
balinasloe, co. galway, galway H53 K 8P4
EI H53 K8P4
Manufacturer Contact
mike dunning
ida business park
balinasloe, co. galway, galway H53 K-8P4
EI   H53 K8P4
MDR Report Key11890683
MDR Text Key255924800
Report Number3005994106-2021-00004
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeEI
PMA/PMN Number
K143561
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 05/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/04/2021
Device Model NumberD1404081675
Device Lot Number21802352
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/26/2021
Was Device Evaluated by Manufacturer? No
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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