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

Model Number	UHP75104
Medical Device Problem Codes	Inflation Problem (1310); Explosion (4006)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The device burst below indicated rated burst pressure.
Event or Problem Description
Follow up report for cc2020-099-ir; mfr report #: 3005994106-2020-00099.
Additional 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
• 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: 10645772
• Report Number: 3005994106-2020-00099
• Device Sequence Number: 16853144
• Product Code: LIT
• UDI-Device Identifier: 08570590020068
• UDI-Public: 08570590020068
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K102645
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/12/2021
• Device Model Number: UHP75104
• Device Lot Number: 21801031
• 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): 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
• Patient Sex: Unknown