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

Model Number EUHP75144

Device Problems Accessory Incompatible (1004); Failure to Fold (1255); Difficult to Open or Close (2921); Mechanical Jam (2983); Failure to Deflate (4060)

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

Event Type  malfunction  

Event Description

During procedure the balloon did not deflate/ refold correctly.There was difficulty in retrieval and guide catheter tip was damaged.No complications occured.

Event Description

Follow up report for (b)(4); mfr report #: 3005994106-2021-00008.

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: mike dunning ; ida business park; balinasloe, co. galway, galway H53 K-8P4 ; EI H53 K8P4
• MDR Report Key: 11890703
• MDR Text Key: 255926392
• Report Number: 3005994106-2021-00008
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08570590020228
• UDI-Public: 08570590020228
• 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: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/15/2022
• Device Model Number: EUHP75144
• Device Lot Number: 21903891
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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