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

Model Number	SRA-DC18-60150
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hardware analysis confirmed the reported issue.The balloon separated at the rx port.The reported failure mode was consistent with a known device issue.
Event or Problem Description
The balloon was used in the proximal popliteal - superficial femoral artery (sfa).After a pass, the balloon was deflated.Upon removal, the surgeon noticed the balloon catheter was outside the sheath.The balloon catheter reportedly broke.The surgeon was able to retrieve the balloon in the distal rapid exchange port.The procedure was successfully completed with the use of a second balloon.Additional information received from the manufacturer representative indicated the event pertained to a radial procedure.During removal, the surgical technician confirmed the balloon was deflated.No resistance was met.Once removed from the sheath, the distal segment remained in the patient.The catheter separated at the rx port.Imaging confirmed the balloon marker bands were outside of the sheath.The surgeon was able to use a snare and retrieve the catheter segment within approximately four minutes.No additional interventions or access points were required.The issue resulted in a procedure delay of approximately four minutes.There was no further impact to the patient.
Event or Problem Description
The balloon was used in the proximal popliteal - superficial femoral artery (sfa).After a pass, the balloon was deflated.Upon removal, the surgeon noticed the balloon catheter was outside the sheath.The balloon catheter reportedly broke.The surgeon was able to retrieve the balloon in the distal rapid exchange port.The procedure was successfully completed with the use of a second balloon.Additional information received from the manufacturer representative indicated the event pertained to a radial procedure.During removal, the surgical technician confirmed the balloon was deflated.No resistance was met.Once removed from the sheath, the distal segment remained in the patient.The catheter separated at the rx port.Imaging confirmed the balloon marker bands were outside of the sheath.The surgeon was able to use a snare and retrieve the catheter segment within approximately four minutes.No additional interventions or access points were required.The issue resulted in a procedure delay of approximately four minutes.The target vessel condition was noted to be very diseased with mixed thrombus morphology.There was no further impact to the patient.

• Brand Name: SUBLIME¿ RADIAL ACCESS 018 RX PTA DILATATION CATHETER
• 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 ; 9525007000
• MDR Report Key: 16550059
• Report Number: 3014687026-2023-00003
• Device Sequence Number: 14938947
• Product Code: LIT
• UDI-Device Identifier: 05391525786445
• UDI-Public: 05391525786445
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2023

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: 03/06/2023
• Device Model Number: SRA-DC18-60150
• Device Lot Number: 22200387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2023
• Supplement Date Received by Manufacturer: 05/01/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 05/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2022
• 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 Age: 79 YR
• Patient Sex: Female
• Patient Weight: 58 KG