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

Model Number	H74939032202210
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulty, froze on wire and shaft break occurred.The target lesion was located in the peripheral artery.A 2.0x220x150 (4f) sterling and a v-18 control wire guidewire were selected for use in the lower extremity to treat peripheral artery disease.During the procedure, the balloon was inflated and deflated.An attempt to remove the balloon off of the wire was made; however, the balloon remained stuck on the wire and the shaft broke.The balloon catheter and the guidewire were removed together from the patient.The procedure was completed with a non-boston scientific 018 guidewire and an alternate balloon.There were no patient complications as a result of this event and the patient fully recovered.
Event or Problem Description
It was reported that removal difficulty, froze on wire and shaft break occurred.The target lesion was located in the peripheral artery.A 2.0x220x150 (4f) sterling and a v-18 control wire guidewire were selected for use in the lower extremity to treat peripheral artery disease.During the procedure, the balloon was inflated and deflated.An attempt to remove the balloon off of the wire was made; however, the balloon remained stuck on the wire and the shaft broke.The balloon catheter and the guidewire were removed together from the patient.The procedure was completed with a non-boston scientific 018 guidewire and an alternate balloon.There were no patient complications as a result of this event and the patient fully recovered.
Additional Manufacturer Narrative
Investigation results: device evaluated by mfr: the sterling device was returned to our post market quality assurance laboratory.The sterling device was returned with a guidewire stuck inside.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed a separation in the inner shaft starting at 127cm and tip damaged.The inner shaft on the balloon was bunching at the tip and the distal end.The guidewire was unable to be removed due to the massive bunching.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported complaint.This concludes the product analysis.Device history record: it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed that the content was sufficient and did not contribute to the reported event; therefore, no updates are required to the document at this time.Investigation conclusion: boston scientific concludes the most probable root cause as adverse event related to procedure because the frozen on the wire was likely caused by pulling on the guidewire as the balloon was inflated causing the guidewire to be stuck.Based on the results of this investigation, no escalation is necessary.

• 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: 24236134
• Report Number: 2124215-2026-05796
• Device Sequence Number: 21128196
• Product Code: LIT
• UDI-Device Identifier: 08714729859970
• UDI-Public: (01)08714729859970(17)281008(10)37660138
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K141112
• 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): 03/12/2026

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: H74939032202210
• Device Catalogue Number: H74939032202210
• Device Lot Number: 0037660138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2025
• 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 Age: 48 YR
• Patient Sex: Unknown