MAUDE Adverse Event Report: CREAGH MEDICAL FIRST CHOICE; PTA CATHETER

Model Number	UHP7588
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Renal Failure (2041)
Date of Event	09/23/2021
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional Manufacturer Narrative
Follow up report for additional information not known at the time of original report, such as, investigation type, findings, and conclusion.
Event or Problem Description
Follow up report for (b)(4); mfr report #: 3005994106-2022-00002.

• Brand Name: FIRST CHOICE
• Common Device Name: PTA 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 Key: 14118608
• Report Number: 3005994106-2022-00002
• Device Sequence Number: 2427623
• Product Code: LIT
• UDI-Device Identifier: 08570590020259
• UDI-Public: 08570590020259
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K102645
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/08/2024
• Device Model Number: UHP7588
• Device Lot Number: 22101856
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2022
• Supplement Date Received by Manufacturer: 03/23/2022
• Initial Report FDA Received Date: 04/15/2022
• Supplement Report FDA Received Date: 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American