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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CREAGH MEDICAL LTD.9 DYNAMIS HP 10MM X 40MM X 75CM PTA CATHETER

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CREAGH MEDICAL LTD.9 DYNAMIS HP 10MM X 40MM X 75CM PTA CATHETER Back to Search Results
Model Number UHP75104
Device Problems Deflation Problem (1149); Retraction Problem (1536); Device-Device Incompatibility (2919); Mechanical Jam (2983)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Difficulty deflating balloon completely and withdrawn balloon from sheath. Balloon deflation required additional 10cc and 20cc syringe use.
 
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Brand NameDYNAMIS HP 10MM X 40MM X 75CM
Type of DevicePTA CATHETER
Manufacturer (Section D)
CREAGH MEDICAL LTD.9
ida business park
ballinasloe, galway H53 H Y09
EI H53 HY09
Manufacturer (Section G)
CREAGH MEDICAL LTD.
ida business park
ballinasloe, galway H53 K 8P4
EI H53 K8P4
Manufacturer Contact
jonathan canavan
ida business park
ballinasloe, galway H53 H-Y09
EI   H53 HY09
MDR Report Key10008109
MDR Text Key200444410
Report Number3005994106-2020-00001
Device Sequence Number1
Product Code LIT
UDI-Device Identifier05391525783338
UDI-Public05391525783338
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113468
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Non-Healthcare Professional
Remedial Action Notification
Type of Report Initial,Followup
Report Date 04/24/2020
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received04/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUHP75104
Device Catalogue NumberUHP75104
Device Lot Number21903331
Was Device Available for Evaluation? No
Date Manufacturer Received03/25/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 04/28/2020 Patient Sequence Number: 1
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