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

Model Number	SRA-DC18-50100
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The balloon was being used during a left radial to periphery procedure.A guide sheath was placed into the right iliac artery.An 0.018" guidewire was placed into the distal popliteal artery.A balloon catheter was placed in the distal superficial femoral artery (sfa) and inflated to 12atm with full apposition.During balloon deflation, blood flow back into the deflator was observed.When retrieving the balloon, only the shaft was removed from the patient's body.The balloon segment was stuck int eh distal fsa.The patient was transported to a hospital for surgical removal.Balloon deflation confirmation was performed via angiogram.Negative pressure was held for approximately 2-3 seconds prior to removal.Very little resistance was experienced during removal.There was no further patient harm.The patient had a follow-up with the physician in two weeks.
Additional Manufacturer Narrative
H3: the proximal catheter segment was returned for analysis.Analysis confirmed shaft separation at the rapid exchange (rx) port.There was approximately 20mm of elongation of the catheter 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: 19373369
• Report Number: 3005994106-2024-00008
• Device Sequence Number: 7703299
• Product Code: LIT
• UDI-Device Identifier: 05391525786353
• UDI-Public: 05391525786353
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 05/22/2024

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: 05/03/2024
• Device Model Number: SRA-DC18-50100
• Device Lot Number: 22200870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2022
• 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