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

Model Number	PTA UHP 14.0MM X 40MM X 75CM
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer has not returned the affected devices, and has not identified the affected batch/lot numbers.
Event or Problem Description
The customer has reported that they are not able to withdraw the balloons they sheath.They are having to remove the sheath each time to remove the balloon they sheath.They are having to remove the sheath each time to remove the balloon.The customer has reported that this has happened on several occasions, but have not provided specific dates.No harm or impact to any patients have been indicated by the customer.
Additional Manufacturer Narrative
Customer has not returned the affected devices, and has not identified the affected batch/lot numbers.Additional manufacturer narrative: this complaint could neither be confirmed or denied as no information was provided pertaining to the batch identification number.The root cause could also not be determined.
Event or Problem Description
The customer has reported that they are not able to withdraw the balloons they sheath.They are having to remove the sheath each time to remove the balloon they sheath.They are having to remove the sheath each time to remove the balloon.The customer has reported that this has happened on several occasions, but have not provided specific dates.No harm or impact to any patients have been indicated by the customer.
Event or Problem Description
Follow-up report to submit additional information not known at time of initial submission.

• Brand Name: FIRST CHOICE UHP
• Common Device Name: PTA CATHETER
• Manufacturer (Section D): CREAGH MEDICAL LTD; ida business park; ballinasloe, H53 K 8P4; EI H53 K8P4
• Manufacturer (Section G): CREAGH MEDICAL LTD; ida business park; ballinasloe, H53 K 8P4; EI H53 K8P4
• Manufacturer Contact: shane costello ; ida business park; ballinasloe, galway H53 K-8P4 ; EI H53 K8P4
• MDR Report Key: 8252073
• Report Number: 3005994106-2019-00001
• Device Sequence Number: 1914952
• Product Code: LIT
• UDI-Device Identifier: 05391525783352
• UDI-Public: 05391525783352
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/11/2018

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
• Operator of Device: Health Professional
• Device Model Number: PTA UHP 14.0MM X 40MM X 75CM
• Device Catalogue Number: UHP75144
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2019
• Supplement Date Received by Manufacturer: 12/11/2019; 12/11/2019
• Initial Report FDA Received Date: 01/16/2019
• Supplement Report FDA Received Date: 05/15/2019; 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other
• Patient Sex: Unknown