MAUDE Adverse Event Report: CREAGH MEDICAL SUBLIME¿ RADIAL ACCESS 018 RX PTA DILATATION CATHETER; Catheter, angioplasty, peripheral, transluminal

Model Number	SRA-DC18-60080
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The balloon catheter was used for a percutaneous transluminal angioplasty (pta) procedure.Radial angioplasty was performed in order to avoid an open procedure.The site reported the balloon burst after inflation to approximately 10 atms.The physician was using the "kissing balloon technique" for bifurcations.During removal, the balloon catheter shaft separated from the main body near the rapid exchange port during removal from a 6fr sheath.The thought was that the site did not allow full deflation of the balloons prior to pulling back into the sheath.The physician had to perform a vessel cutdown to retrieve the separated segments and finish with endarterectomy.The site indicated the balloons separated in the right superficial femoral artery (sfa) and proximal popliteal artery.Multiple attempts at deflation were made.The wire was not removed.The balloon separated approximately 10-20 cm from the balloon markerband.The further intervention of endarterectomy was required for the calcified iliac artery and balloon segment removal.Both balloon segments were intact upon removal.The entire procedure lasted approximately seven hours with a four hour delay due to the balloon separation and cutdown.
Additional Manufacturer Narrative
Only one balloon segment was returned.This segment included the catheter hub to rapid exchange (rx) port.The distal portion of the returned section showed outer catheter elongation of approximately 11cm past the skive.

• 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 ; 9525007598
• MDR Report Key: 20248145
• Report Number: 3005994106-2024-00013
• Device Sequence Number: 15281853
• Product Code: LIT
• UDI-Device Identifier: 05391525786414
• UDI-Public: 05391525786414
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 09/18/2024

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: 06/18/2026
• Device Model Number: SRA-DC18-60080
• Device Lot Number: 22301040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2023
• 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