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

Model Number	24700
Medical Device Problem Codes	Entrapment of Device (1212); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.Good faith effort attempts were made to try and retrieve the device batch or lot number and additional details regarding the reported event, but further information was unable to be obtained.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that balloon could not be removed from the guidewire.The target lesion was located in the peripheral artery.A 5.0mmx100mmx135cm (4f) sterling balloon was advanced for dilation.However, after inflation, it was noted that the balloon could not be removed from the guidewire.As a result, both the guidewire and the balloon had to be removed together and reselect the vessel with a new guidewire.The procedure was then completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Update to field d4: lot number: 0034512228 device evaluated by mfr: the sterling balloon catheter with a 0.018" guidewire stuck inside were returned to our post market quality assurance laboratory.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple buckling and multiple stretching along the shaft.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the froze on wire.
Event or Problem Description
It was reported that balloon could not be removed from the guidewire.The target lesion was located in the peripheral artery.A 5.0mmx100mmx135cm (4f) sterling balloon was advanced for dilation.However, after inflation, it was noted that the balloon could not be removed from the guidewire.As a result, both the guidewire and the balloon had to be removed together and reselect the vessel with a new guidewire.The procedure was then completed with another of the same device.There were no patient complications as a result of this event.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 22009629
• Report Number: 2124215-2025-28439
• Device Sequence Number: 5229137
• Product Code: DQY
• UDI-Device Identifier: 08714729122814
• UDI-Public: (01)08714729122814
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2025

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 Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0034512228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2024
• 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