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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CREAGH MEDICAL FIRST CHOICE PERIPHERAL ANGIOPLASTY BALLOON CATHETER

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CREAGH MEDICAL FIRST CHOICE PERIPHERAL ANGIOPLASTY BALLOON CATHETER Back to Search Results
Model Number UHP7588
Device Problem Mechanical Problem (1384)
Patient Problem Renal Failure (2041)
Event Date 09/23/2021
Event Type  malfunction  
Event Description
Customer reports when inflating balloon to 22psi, which was the target, the balloon burst at 21 psi. There was no patient injury reported. Minor procedural delayed was report while the new device was prepped and inserted. The new device was used to complete the procedure.
 
Manufacturer Narrative
While attempting to use device, pn: uhp7588, during an angioplasty procedure, the customer reported a balloon malfunction while inflating the balloon to target pressure of 22 psi, the balloon burst at 21 psi. The device, pn: uhp7588, was removed with no further issues. A new device was prepped and used to complete the procedure with minor procedural delay experienced. There was no harm to the patient reported.
 
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Brand NameFIRST CHOICE
Type of DevicePERIPHERAL ANGIOPLASTY BALLOON CATHETER
Manufacturer (Section D)
CREAGH MEDICAL
ida business park
creagh road
ballinasloe, co. galway, ireland
EI
Manufacturer (Section G)
CREAGH MEDICAL
ida business park
creagh road
ballinasloe, co. galway, ireland
EI
Manufacturer Contact
holly ramirez
7905 golden triangle drive
eden prairie, MN 55344
MDR Report Key14118608
MDR Text Key289438361
Report Number3005994106-2022-00002
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K102645
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/11/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUHP7588
Device Lot Number22101856
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/23/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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