MAUDE Adverse Event Report: CREAGH MEDICAL SUBLIME¿ 014 RX PTA BALLOON DILATATION CATHETER; Catheter, angioplasty, peripheral, transluminal

Model Number	SRA-DC14-20150
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: the balloon catheter was returned for analysis.Analysis confirmed the balloon separation.The distal tip of the balloon was not returned.
Event or Problem Description
The balloon catheter used during a percutaneous transluminal angioplasty (pta) procedure of a calcified tibial artery.The balloon was inflated three times.On the third inflation, the balloon ruptured.The balloon was inflated to 8atm, 4atm, and 6atm respectively.The physician attempted to remove the balloon.In doing so, the distal portion of the balloon separated and was left in the patient's artery.Several attempts were made to retrieve the balloon segment, all of which were unsuccessful.The physician was able to stent the artery, ensuring the balloon segment would not migrate.There was no further patient harm.The procedure was delayed due to the unsuccessful retrieval attempts.

• Brand Name: SUBLIME¿ 014 RX PTA BALLOON 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): SURMODICS INC; 7905 golden triangle drive; suite 190; eden prairie MN 55344
• Manufacturer Contact: phil haney ; 7905 golden triangle drive; suite 190; eden prairie, MN 55344 ; 9525007598
• MDR Report Key: 20839680
• Report Number: 3005994106-2024-00017
• Device Sequence Number: 3759460
• Product Code: LIT
• UDI-Device Identifier: 05391525783673
• UDI-Public: 05391525783673
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K200700
• 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): 12/03/2024

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: 06/12/2025
• Device Model Number: SRA-DC14-20150
• Device Lot Number: 22201239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2022
• 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: 54 YR
• Patient Sex: Male