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	02/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hardware analysis confirmed the reported issue.The balloon catheter separated at the rx port.The reported failure mode was consistent with a known device issue.
Event or Problem Description
The balloon was being used in a superficial femoral artery (sfa) procedure with radial access.After the second inflation/deflation, the balloon was advanced distal in the target artery for the third pass.The balloon was deflated completely and when pulling back, the balloon shaft separated in the vessel.The balloon was pulled less than approximately 1mm before the issue occurred.The distal balloon/shaft segment was left in the target vessel and the proximal segment was removed.The surgeon was able to retrieve the catheter segment in the vessel.Two secondary access sites were required to snare the separated segment.Another balloon was also required for tamponade.It was noted the balloon was deflated with an electronic deflator.Furthermore, the target vessel was highly calcified.Prior to the procedure, the surgeon stated the balloon was "sticky" when removing from packaging.The issue resulted in a procedure delay of approximately three hours.There was no further impact to the patient.
Event or Problem Description
Additional information received from the manufacturer representative indicated the target vessel was approximately 5-6mm.Regarding the report of "sticky balloon", there was no restriction when unsheathing the balloon protector.It was noted that force was required to cross the lesion.

• 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: 16549971
• Report Number: 3014687026-2023-00002
• Device Sequence Number: 6042443
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2023

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: 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: 02/21/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2023
• Supplement Date Received by Manufacturer: 03/16/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 03/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Unknown
• Patient Weight: 109 KG