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

Model Number UHP7588

Device Problems Material Puncture/Hole (1504); Material Rupture (1546)

Patient Problem No Information (3190)

Event Date 07/30/2018

Event Type  malfunction  

Event Description

Customer has reported that during procedure the balloon popped when they took it out there was a pin hole in it.

• Brand Name: FIRST CHOICE
• Type of Device: PTA CATHETER
• Manufacturer (Section D): CREAGH MEDICAL LTD; ida business park; ballinasloe, H53 K 8P4; EI H53 K8P4
• Manufacturer (Section G): CREAGH MEDICAL LTD; ida business park; ballinasloe, H53 K 8P4; EI H53 K8P4
• Manufacturer Contact: shane costello ; ida business park; ballinasloe, galway H53 K-8P4 ; EI H53 K8P4
• MDR Report Key: 8522131
• MDR Text Key: 142366117
• Report Number: 3005994106-2019-00006
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113468
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 04/17/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/27/2020
• Device Model Number: UHP7588
• Device Catalogue Number: UHP7588
• Device Lot Number: 21700266
• Was Device Available for Evaluation?: Yes

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial