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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CREAGH MEDICAL LTD. FIRST CHOICE PTA BALLOON DILATATION CATHETER

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CREAGH MEDICAL LTD. FIRST CHOICE PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number EUHP75124
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/25/2019
Event Type  malfunction  
Event Description
The physician attempted to insert the device into the patient, but they were not able to insert the device into the patient. The device was ripped during this process.
 
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Brand NameFIRST CHOICE
Type of DevicePTA 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
jonathan canavan
ida business park
balinasloe, co. galway, galway H53 K-8P4
EI   H53 K8P4
MDR Report Key11015427
MDR Text Key223814636
Report Number3005994106-2020-00115
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 12/15/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/16/2021
Device Model NumberEUHP75124
Device Lot Number21801943
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/01/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/16/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/16/2018
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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