MAUDE Adverse Event Report: CREAGH MEDICAL SUBLIME¿ RADIAL ACCESS 018 RX PTA DILATATION CATHETER; PERIPHERAL ANGIOPLASTY BALLOON CATHETER

Model Number	SRA-DC18-60150
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hardware analysis confirmed the reported issue.The balloon separation observed was consistent with trying to remove a balloon that was not fully deflated.Due to the balloon being in segments, the balloon could not be tested for leak or rupture through inflation.
Event or Problem Description
During the procedure when the surgeon was finished with ballooning, resistance was met when removing the balloon through the guide sheath.The surgeon felt the balloon burst and saw under fluoroscopy that the balloon had burst in the sheath.The surgeon then used another balloon to plug the end of the sheath to trap the remaining pieces of the balloon in the sheath.The surgeon then pulled everything out.There was no impact to patient outcome.Additional information received from the manufacturer representative indicated the surgical technician used the same technique when deflating the balloon as usual.Fluoroscopy was also performed to confirm deflation.

• Brand Name: SUBLIME¿ RADIAL ACCESS 018 RX PTA DILATATION CATHETER
• Common Device Name: PERIPHERAL ANGIOPLASTY BALLOON CATHETER
• 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 ; 9525007000
• MDR Report Key: 16392120
• Report Number: 3014687026-2023-00001
• Device Sequence Number: 5705659
• Product Code: LIT
• UDI-Device Identifier: 05391525786445
• UDI-Public: 05391525786445
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K211044
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/16/2023

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: 02/23/2023
• Device Model Number: SRA-DC18-60150
• Device Lot Number: 22200125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2023
• Initial Report FDA Received Date: 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2022
• 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
• Patient Sex: Unknown