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

Model Number	UHP75104
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unit has been requested from the customer, has not been returned as of 08th november 2018.
Event or Problem Description
Customer reported a balloon rupture at 16 atm.No patient injury reported.
Event or Problem Description
Customer reported a balloon rupture at 16 atm.No patient injury reported.
Additional Manufacturer Narrative
Unit has been requested from the customer, has not been returned as of 08th november 2018.Additional manufacturer narrative: the unit was not ultimately returned by the customer.A review of the batch history records and process controls has been carried out.The units were processed to the correct validated parameters.All units from this batch were subjected to a 100% final inspection process, including 100% wet leak testing.All units were inspected under a 10x vision system and all observed defective units were removed.All manufacturing operations were completed by fully trained operators.All components used in the manufacture of this batch are consistent with that used on all pta uhp products.The current inspection & testing controls in place are deemed effective.All associated batch records have been reviewed and no anomalies or unusual data readings have been noted during this investigation.The customer has not informed surmodics of any other suspected lots.No unit has been returned for evaluation therefore this complaint is unconfirmed and the root cause inconclusive.Corrected data in follow-up #1: section b1: "adverse event" was incorrectly selected, this has been corrected to select "product problem" instead.Section d1: a incorrect device brand name "dynamis" was provided, this has been updated to the correct brand name "first choice uhp".Section e1: the initial reporter was incorrectly identified as being the manufacturer, this has been updated to include the details of the distributor who was the initial reporter.
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: eoin mcevoy ; ida business park; ballinasloe, galway H53 K-8P4 ; EI H53 K8P4
• MDR Report Key: 8183747
• Report Number: 3005994106-2018-00005
• Device Sequence Number: 19336863
• Product Code: LIT
• UDI-Device Identifier: 08570590020082
• UDI-Public: 08570590020082
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/08/2018

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 Model Number: UHP75104
• Device Lot Number: 21701327
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/10/2018; 10/10/2018
• Initial Report FDA Received Date: 12/20/2018
• Supplement Report FDA Received Date: 05/15/2019; 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown