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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CREAGH MEDICAL LTD. FIRST CHOICE 0.035" WIREGUIDED PTA CATHETER

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CREAGH MEDICAL LTD. FIRST CHOICE 0.035" WIREGUIDED PTA CATHETER Back to Search Results
Model Number EUHP75124
Device Problem Difficult to Open or Close (2921)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/16/2020
Event Type  malfunction  
Event Description
First choice balloon would not deflate after inflations. During intervention, product was advanced over the wire, inflated with no issues, but when full negative was pulled through inflation devices, the balloon only came down in the middle. The lab staff even attached a 20 or 30cc string and pulled a manual negative as well and both ends remained partially inflated. Through multiple attempts with no success, they tried pulling through the sheaths and all remaining contrast media within the balloon was locked at the end of the sheath but would not fully withdraw through sheaths. To clarify, the balloon wouldn't deflate before the balloon was ever pulled back to the sheath. The devices and assembly were pulled back and removed as one unit. Note, there were three first choice balloons involved in this single event. There were 2 each of the 12x4 sizes (uhp75124) and 1 each of the 8x4 size (uhp7584). This report discusses one of the 12x4 devices, euhp75124.
 
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Brand NameFIRST CHOICE
Type of Device0.035" WIREGUIDED PTA CATHETER
Manufacturer (Section D)
CREAGH MEDICAL LTD.
ida business park
creagh road
ballinasloe, co. galway H53 K 8P4
EI H53 K8P4
Manufacturer (Section G)
CREAGH MEDICAL LTD.
ida business park
creagh road
ballinasloe, co. galway H53 K 8P4
EI H53 K8P4
Manufacturer Contact
jonathan canavan
ida business park
creagh road
ballinasloe, co. galway H53 K-8P4
EI   H53 K8P4
MDR Report Key10645773
MDR Text Key213032703
Report Number3005994106-2020-00097
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 10/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberEUHP75124
Device Lot Number22001203
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/22/2020
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

Patient Treatment Data
Date Received: 10/07/2020 Patient Sequence Number: 1
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