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

• Brand Name: FIRST CHOICE
• Type of Device: PERIPHERAL 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 Key: 14118608
• MDR Text Key: 289438361
• Report Number: 3005994106-2022-00002
• Device Sequence Number: 1
• Product Code: LIT
• 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
• Report Date: 04/11/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: UHP7588
• Device Lot Number: 22101856
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2022
• 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