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

Model Number EUHP75124

Device Problems Difficult to Insert (1316); Mechanical Problem (1384); Material Split, Cut or Torn (4008); Separation Problem (4043)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/25/2019

Event Type  malfunction  

Event Description

The physician attempted to insert the device into the patient, but they were not able to insert the device into the patient.The device was ripped during this process.

Event Description

Follow up report for (b)(6); mfr report #: 3005994106-2020-00115.

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: jonathan canavan ; ida business park; balinasloe, co. galway, galway H53 K-8P4 ; EI H53 K8P4
• MDR Report Key: 11015427
• MDR Text Key: 223814636
• Report Number: 3005994106-2020-00115
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08570590020242
• UDI-Public: 08570590020242
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K143561
• 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: 12/15/2020

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: 08/16/2021
• Device Model Number: EUHP75124
• Device Lot Number: 21801943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Initial Date Manufacturer Received: 11/16/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 11/16/2020
• Supplement Dates FDA Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2018
• 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