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

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.

Manufacturer Narrative

Follow up report for additional information not known at the time of original report, such as, investigation type, findings, and conclusion.

Event Description

Follow up report for (b)(4); mfr report #: 3005994106-2022-00002.

• Brand Name: FIRST CHOICE
• Type of Device: 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
• MDR Text Key: 289438361
• Report Number: 3005994106-2022-00002
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08570590020259
• UDI-Public: 08570590020259
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102645
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 03/23/2022
• Initial Date FDA Received: 04/15/2022
• Supplement Dates Manufacturer Received: 03/23/2022
• Supplement Dates FDA Received: 09/02/2022
• 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
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American