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

Model Number	H74939148301510
Medical Device Problem Codes	Fluid/Blood Leak (1250); Inflation Problem (1310); Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon was cracked, resulting in liquid leakage and inflation failure.The 100% stenosed target lesion was located in the mildly tortuous and moderately calcified superficial femoral artery.A 3.0mm x 150mm x 150cm sterling sl balloon catheter was advance for dilation.During the procedure, it was noted that the balloon was cracked, resulting in liquid leakage and inflation failure.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that the balloon was cracked, resulting in liquid leakage and inflation failure.The 100% stenosed target lesion was located in the mildly tortuous and moderately calcified superficial femoral artery.A 3.0mm x 150mm x 150cm sterling sl balloon catheter was advance for dilation.During the procedure, it was noted that the balloon was cracked, resulting in liquid leakage and inflation failure.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device evaluated by mfr: the sterling device was returned to our post market quality assurance laboratory.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination showed the balloon had a rupture.Microscopic examination revealed that the balloon had two ruptures, one at 10cm from the tip and another 12cm.Inspection of the remainder of the device presented no other damage or irregularities.This concludes the product analysis.
Additional Manufacturer Narrative
E1 - initial reporter zip/post code: updated.Device evaluated by mfr: the sterling device was returned to our post market quality assurance laboratory.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination showed the balloon had a rupture.Microscopic examination revealed that the balloon had two ruptures, one at 10cm from the tip and another 12cm.Inspection of the remainder of the device presented no other damage or irregularities.This concludes the product analysis.
Event or Problem Description
It was reported that the balloon was cracked, resulting in liquid leakage and inflation failure.The 100% stenosed target lesion was located in the mildly tortuous and moderately calcified superficial femoral artery.A 3.0mm x 150mm x 150cm sterling sl balloon catheter was advance for dilation.During the procedure, it was noted that the balloon was cracked, resulting in liquid leakage and inflation failure.The procedure was completed with another of the same device.There were no patient complications as a result of this event.

• 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: 22543616
• Report Number: 2124215-2025-48297
• Device Sequence Number: 6975288
• Product Code: DQY
• UDI-Device Identifier: 08714729782315
• UDI-Public: (01)08714729782315(17)261022(10)35117099
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 11/21/2025

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: H74939148301510
• Device Catalogue Number: H74939148301510
• Device Lot Number: 0035117099
• 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: 06/26/2025
• Supplement Date Received by Manufacturer: 10/06/2025; 10/28/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 10/27/2025; 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2024
• 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: 61 YR
• Patient Sex: Male
• Patient Weight: 60 KG