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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CREAGH MEDICAL LTD. DYNAMIS AV 0.035" WIREGUIDED PTA CATHETER

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CREAGH MEDICAL LTD. DYNAMIS AV 0.035" WIREGUIDED PTA CATHETER Back to Search Results
Model Number UHP75124
Device Problem Fluid Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/28/2020
Event Type  malfunction  
Event Description
Pta case in which the physician used three 12x4 first choice balloons all of which experienced issues. One burst, one leaked, and one came apart where it connects to the syringe. This report focuses on the leak device. All three devices had the same lot number and expiration date (lot3 22001203, exp- 6/2/23).
 
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Brand NameDYNAMIS AV
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 Key10409465
MDR Text Key209815838
Report Number3005994106-2020-00086
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 08/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUHP75124
Device Lot Number22001203
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Distributor Facility Aware Date07/28/2020
Event Location No Information
Date Manufacturer Received07/28/2020
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

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