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

Model Number	SRA-DC18-50060
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: the device was returned for analysis.Device analysis confirmed the reported issue.The distal end of the balloon was deformed in a manner in which removal from the accompanying guide sheath was not possible.The returned balloon segment was unable to passed through the returned guide sheath with attempted.
Event or Problem Description
The balloon was used during an angioplasty procedure.The guide sheath was inserted into the superficial femoral artery (sfa) without issue.During balloon removal, the balloon got stuck inside the guide sheath and would not pull through.The physician tried to pull, but the sheath was removing at the same time as the balloon.The physician thought the balloon was unstuck, but once removed, the balloon segment was not attached to the hub segment.The balloon segment (which contained the rapid exchange (rx) junction) was stuck in the guide sheath.The separated segment was retrieved with removal of the guide sheath.It was noted the physician confirmed balloon deflation under fluoroscopy.There was no impact to patient outcome or patient harm.The reported issue resulted in a procedure delay of approximately 20 minutes.

• 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: 17813957
• Report Number: 3005994106-2023-00007
• Device Sequence Number: 7249118
• Product Code: LIT
• UDI-Device Identifier: 05391525786339
• UDI-Public: 05391525786339
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 09/25/2023

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: 07/25/2024
• Device Model Number: SRA-DC18-50060
• Device Lot Number: 22201819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 09/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2023
• 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
• Patient Sex: Unknown