MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING; CATHETER, PERCUTANEOUS

Model Number	24700
Medical Device Problem Codes	Material Rupture (1546); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.When removing a 5.0mmx40mmx135cm sterling balloon catheter from the packaging, it was noticed that the balloon material was tear, and a shaft was kinked.The procedure was completed with a different device.There were no patient complications nor injuries were reported.
Event or Problem Description
It was reported that balloon rupture occurred.When removing a 5.0mmx40mmx135cm sterling balloon catheter from the packaging, it was noticed that the balloon material was tear, and a shaft was kinked.The procedure was completed with a different device.There were no patient complications nor injuries were reported.
Additional Manufacturer Narrative
Returned product consisted of a sterling balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual inspection revealed that the guidewire lumen within the balloon was curved with a wavy appearance and the balloon is deformed.Microscopic examination no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the guidewire lumen is wavy in appearance inside the balloon and the balloon is deformed.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16246218
• Report Number: 2124215-2023-02739
• Device Sequence Number: 6406715
• Product Code: DQY
• UDI-Device Identifier: 08714729122906
• UDI-Public: 08714729122906
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K053116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2023

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: 03/09/2025
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0029018782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2023
• Supplement Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 01/26/2023
• Supplement Report FDA Received Date: 03/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2022
• 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
• Patient Sex: Unknown