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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CREAGH MEDICAL LTD. ADVANCE SERENITY¿ 18 018 HYDROPHILIC COATED OTW PTA BALLOON DILATATION CATHETER

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CREAGH MEDICAL LTD. ADVANCE SERENITY¿ 18 018 HYDROPHILIC COATED OTW PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number SER18-150-30-220
Device Problem Failure to Deflate (4060)
Patient Problem Insufficient Information (4580)
Event Date 09/10/2021
Event Type  malfunction  
Event Description
The balloon would not deflate, and the user was unable to remove the device from the body properly.
 
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Brand NameADVANCE SERENITY¿ 18
Type of Device018 HYDROPHILIC COATED OTW PTA BALLOON DILATATION 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
martin crehan
ida business park
balinasloe, co. galway, galway H53 K-8P4
EI   H53 K8P4
MDR Report Key12681507
MDR Text Key280510933
Report Number3005994106-2021-00094
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeEI
PMA/PMN Number
K180007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 10/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSER18-150-30-220
Device Lot Number22101416
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/30/2021
Date Manufacturer Received09/22/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/29/2021
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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