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

Model Number	H74939032501210
Medical Device Problem Codes	Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: 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 a ruptures at 7cm from the tip and the shaft had multiple kinks.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
Reportable based on device analysis completed on 22oct2025.It was reported that the balloon was unable to cross the lesion occurred.The 100% stenosed target lesion was located in the severely tortuous and severely calcified vessel.A 5.0x120x150 sterling catheter was selected for renal artery percutaneous transluminal angioplasty (pta) procedures.The device did not advance well within the blood vessels.The procedure was completed with another of same device.There were no patient complication as the result of this event.However, device analysis revealed that the balloon had a rupture at 7cm from the tip.

• 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: 23542543
• Report Number: 2124215-2025-82004
• Device Sequence Number: 9448926
• Product Code: LIT
• UDI-Device Identifier: 08714729845348
• UDI-Public: (01)08714729845348(17)270123(10)33275883
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K132430
• 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
• Report Date (Section B): 11/13/2025

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: H74939032501210
• Device Catalogue Number: H74939032501210
• Device Lot Number: 0033275883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2024
• 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