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U.S. Department of Health and Human Services

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

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CREAGH MEDICAL LTD. PTA BALLOON CATHETER Back to Search Results
Device Problem Material Rupture (1546)
Patient Problem Failure of Implant (1924)
Event Date 05/18/2020
Event Type  Injury  
Event Description
Balloon that burst inside a patient today and the patient was transported to the emergency department with the balloon still in the patient. Rep is collecting more information. Customer feedback stated: that upon asking for further information it became evident that a stent had been implanted, and came into contact with the metal stent and this contact ruptured the balloon.
 
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Type of DevicePTA BALLOON CATHETER
Manufacturer (Section G)
CREAGH MEDICAL LTD.
ida business park
ballinasloe, co. galway galway H53 K 8P4
EI H53 K8P4
Manufacturer Contact
jonathan canavan
ida business park
ballinasloe, co. galway galway H53 K-8P4
EI   H53 K8P4
MDR Report Key10143544
MDR Text Key194884631
Report Number3005994106-2020-00055
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeEI
PMA/PMN Number
K113468
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 06/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/18/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/11/2020
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: 06/11/2020 Patient Sequence Number: 1
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