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

Model Number EUHP75124

Device Problems Difficult to Open or Close (2921); Failure to Deflate (4060)

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

Event Date 09/16/2020

Event Type  malfunction  

Event Description

First choice balloon would not deflate after inflations.During intervention, product was advanced over the wire, inflated with no issues, but when full negative was pulled through inflation devices, the balloon only came down in the middle.The lab staff even attached a 20 or 30cc string and pulled a manual negative as well and both ends remained partially inflated.Through multiple attempts with no success, they tried pulling through the sheaths and all remaining contrast media within the balloon was locked at the end of the sheath but would not fully withdraw through sheaths.To clarify, the balloon wouldn't deflate before the balloon was ever pulled back to the sheath.The devices and assembly were pulled back and removed as one unit.Note, there were three first choice balloons involved in this single event.There were 2 each of the 12x4 sizes (uhp75124) and 1 each of the 8x4 size (uhp7584).This report discusses one of the 12x4 devices, euhp75124.

Event Description

Follow up report for cc2020-097-ir; mfr report #: 3005994106-2020-00097.

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; creagh road; ballinasloe, co. galway H53 K 8P4; EI H53 K8P4
• Manufacturer (Section G): CREAGH MEDICAL LTD.; ida business park; creagh road; ballinasloe, co. galway H53 K 8P4; EI H53 K8P4
• Manufacturer Contact: jonathan canavan ; ida business park; creagh road; ballinasloe, co. galway H53 K-8P4 ; EI H53 K8P4
• MDR Report Key: 10645773
• MDR Text Key: 213032703
• Report Number: 3005994106-2020-00097
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08570590020068
• UDI-Public: 08570590020068
• 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: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/03/2023
• Device Model Number: EUHP75124
• Device Lot Number: 22001203
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/22/2020
• Initial Date FDA Received: 10/07/2020
• Supplement Dates Manufacturer Received: 09/22/2020
• Supplement Dates FDA Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Required Intervention