MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING SL; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	H74939148351510
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Detailed information regarding the return status was not provided to bsc.A good-faith effort was made to obtain the necessary information, however, no information has been received to date regarding when the device will be returned.
Event or Problem Description
It was reported that balloon perforated occurred.The target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A 3.5mm x 150mm x 150cm sterling sl was advanced for dilatation.During the procedure, a pressure drop was observed during the initial inflation, which was maintained for approximately 30 seconds.The balloon head was subsequently found to be perforated.The procedure was completed using with another of the same device.The patient was stable post procedure and there were no complications reported as a result of this event.
Event or Problem Description
It was reported that balloon perforated occurred.The target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A 3.5mm x 150mm x 150cm sterling sl was advanced for dilatation.During the procedure, a pressure drop was observed during the initial inflation, which was maintained for approximately 30 seconds.The balloon head was subsequently found to be perforated.The procedure was completed using with another of the same device.The patient was stable post procedure and there were no complications reported as a result of this event.
Additional Manufacturer Narrative
Device analysis: the returned product consisted of a sterling balloon catheter.The outer shaft, inner shaft, balloon, and tip were visually and microscopically examined, with no issues observed.Functional testing was performed and completed without any abnormalities.Examination of the remainder of the device revealed no damage or irregularities.Device history record review: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations that 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.Conclusion: based on a thorough review of the reported complaint, the most probable cause was determined to be no problem detected, as no issues were identified during analysis.

• Brand Name: STERLING SL
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• 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: 24069941
• Report Number: 2124215-2026-02474
• Device Sequence Number: 9387773
• Product Code: LIT
• UDI-Device Identifier: 08714729782353
• UDI-Public: (01)08714729782353(17)260108(10)33173686
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K093720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2026

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 Expiration Date: 01/08/2026
• Device Model Number: H74939148351510
• Device Catalogue Number: H74939148351510
• Device Lot Number: 0033173686
• 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: 12/17/2025
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2024
• 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 Age: 72 YR
• Patient Sex: Male