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

Model Number UHP75104

Device Problems Burst Container or Vessel (1074); Material Rupture (1546)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

While physician performing the fistulogram procedure, the balloon burst occurred before reaching the burst rate, according to the rate stated on the packaging.

Event Description

Follow up report for (b)(6); mfr report #: 3005994106-2021-00001.

Manufacturer Narrative

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

• Brand Name: FIRST CHOICE
• Type of Device: PTA CATHETER
• Manufacturer (Section D): CREAGH MEDICAL LTD.; ida business park; balinasloe, co. galway, galway H53 K 8P4; EI H53 K8P4
• Manufacturer (Section G): CREAGH MEDICAL LTD.; ida business park; balinasloe, co. galway, galway H53 K 8P4; EI H53 K8P4
• Manufacturer Contact: kevin conroy ; ida business park; balinasloe, co. galway, galway H53 K-8P4 ; EI H53 K8P4
• MDR Report Key: 11464545
• MDR Text Key: 242381508
• Report Number: 3005994106-2021-00001
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08570590020082
• UDI-Public: 08570590020082
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K102645
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/08/2023
• Device Model Number: UHP75104
• Device Lot Number: 22002743
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2020
• 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