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

Model Number	EUHP75124
Medical Device Problem Codes	Difficult to Open or Close (2921); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2020
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional Manufacturer Narrative
Follow up report for additional information not known at the time of original report, such as, investigation type, findings, and conclusion.
Event or Problem Description
Follow up report for cc2020-098-ir; mfr report #: 3005994106-2020-00098.

• Brand Name: FIRST CHOICE
• Common Device Name: 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: 10645749
• Report Number: 3005994106-2020-00098
• Device Sequence Number: 19542196
• Product Code: LIT
• UDI-Device Identifier: 08570590020068
• UDI-Public: 08570590020068
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K143561
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 06/03/2023
• Device Model Number: EUHP75124
• Device Lot Number: 22001203
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 10/07/2020
• Supplement Report FDA Received Date: 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown