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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CREAGH MEDICAL LTD. FIRST CHOICE; PTA CATHETER
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CREAGH MEDICAL LTD. FIRST CHOICE; PTA CATHETER Back to Search Results
Model Number EUHP75124
Device Problems Inflation Problem (1310); Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/10/2020
Event Type  malfunction  
Event Description
The 12 x 4 x 75 direct access balloon was attempted to use and noticed a small hole on the balloon and would not inflate to its full potential.
 
Manufacturer Narrative
Follow up report for additional information not known at the time of original report, such as, investigation type, findings, and conclusion.
 
Event Description
Follow up report for cc2020-113-ir' mfr report #: 3005994106-2020-00113.
 
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Brand Name
FIRST CHOICE
Type of Device
PTA 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 Key11015293
MDR Text Key229582032
Report Number3005994106-2020-00113
Device Sequence Number1
Product Code LIT
UDI-Device Identifier08570590020242
UDI-Public08570590020242
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,Followup
Report Date 12/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/03/2023
Device Model NumberEUHP75124
Device Lot Number22001172
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/01/2020
Date Manufacturer Received11/16/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/03/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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