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

Model Number UHP7588

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

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

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.

Manufacturer Narrative

This complaint could neither be confirmed, or the root cause determined.The device was not returned for evaluation.A review of the batch history records and process controls has been carried out.The units were processed to the correct validated parameters.All units from this batch were subjected to a 100% final inspection process, including 100% wet leak testing.All units were inspected under a 10x vision system and all observed defective units were removed.All manufacturing operations were completed by fully trained operators.The current inspection & testing controls in place are deemed effective.All associated batch records have been reviewed and no anomalies or unusual data readings have been noted during this investigation.This failure mode is documented in the design fmea.Conclusion: the root cause of this issue is currently unknown.

Event Description

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

Event Description

Follow-up report to submit additional information not known at time of initial submission.

• 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
• UDI-Device Identifier: 05391525783314
• UDI-Public: 05391525783314
• 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,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 04/17/2019

1 Device was Involved in the Event

1 Patient was 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: Health Professional
• Device Expiration Date: 02/27/2020
• Device Model Number: UHP7588
• Device Catalogue Number: UHP7588
• Device Lot Number: 21700266
• Was Device Available for Evaluation?: Yes
• 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
• Patient Sequence Number: 1