MAUDE Adverse Event Report: CREAGH MEDICAL FIRST CHOICE; Catheter, angioplasty, peripheral, transluminal

Model Number	UHP7564
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: to date, the device had not been returned.If returned, a supplemental mdr will be submitted for analysis results.
Event or Problem Description
The device was used during a fistulogram procedure.The 0.035" hydrophilic guide wire was placed through a 6fr introducer sheath.The site was able to traverse two lesions.However, there was difficulty loading the balloon onto the wire, despite flushing the balloon several times and making sure the guide wire was moistened as well.The physician was ultimately able to load the balloon, but was only able to advance a few centimeters and then the balloon would no longer advance.The balloon was removed, and a second balloon was used.However, the second balloon would also not advance on the guidewire; also reported as defective.The second balloon had ultimately frayed the hydrophilic coating of the guidewire.The issue resulted in the inability of loading anything on the guidewire.The site did not have a wire cutter, so the wire and balloon were removed, and the site had to start over.The site was then unable to re-cross the lesions.The procedure was aborted and rescheduled for the hospital operating room with an anesthesiologist.There was no reported procedure delay.There was no further impact to the patient.

• Brand Name: FIRST CHOICE
• Common Device Name: Catheter, angioplasty, peripheral, transluminal
• Manufacturer (Section D): CREAGH MEDICAL; ida business park; creagh road; ballinasloe, co. galway H53 K 8P4; EI H53 K8P4
• Manufacturer (Section G): CREAGH MEDICAL; ida business park; creagh road; ballinasloe, co. galway H53 K 8P4; EI H53 K8P4
• Manufacturer Contact: phil haney ; 7905 golden triangle drive; suite 190; eden prairie, MN 55344 ; 9525007598
• MDR Report Key: 17298372
• Report Number: 3005994106-2023-00003
• Device Sequence Number: 17907808
• Product Code: LIT
• UDI-Device Identifier: 08570590020044
• UDI-Public: 08570590020044
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/11/2023

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: 10/08/2025
• Device Model Number: UHP7564
• Device Lot Number: 22202330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2023
• Initial Report FDA Received Date: 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2022
• 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