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

Model Number	EUHP75144
Medical Device Problem Codes	Accessory Incompatible (1004); Failure to Fold (1255); Difficult to Open or Close (2921); Mechanical Jam (2983); Failure to Deflate (4060)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem 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 or Problem Description
Follow up report for (b)(4); mfr report #: 3005994106-2021-00008.
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; 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
• Report Number: 3005994106-2021-00008
• Device Sequence Number: 16944472
• Product Code: LIT
• UDI-Device Identifier: 08570590020228
• UDI-Public: 08570590020228
• 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): 05/26/2021

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: 10/15/2022
• Device Model Number: EUHP75144
• Device Lot Number: 21903891
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2021
• Supplement Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 05/26/2021
• 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