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

Model Number	24690
Medical Device Problem Codes	Nonstandard Device (1420); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that a balloon rupture occurred.The target lesion was located in the shunt.A 4.0mmx40mmx135cm (4f) sterling balloon catheter was advanced for dilatation.During the procedure, resistance was encountered during insertion, and the sheath was noted to be bent.The balloon was forcefully advanced, and rupture occurred within the sheath prior to inflation.Damage to the distal tip of the balloon was observed.The device was removed, and the procedure was completed with another of same device.There were no patient complications as a result of this event, and the patient remained stable post-procedure.
Additional Manufacturer Narrative
B5: describe event or problem: updated to include new information obtained.
Event or Problem Description
It was reported that a balloon rupture occurred.The target lesion was located in the shunt.A 4.0mmx40mmx135cm (4f) sterling balloon catheter was advanced for dilatation.During the procedure, resistance was encountered during insertion, and the sheath was noted to be bent.The balloon was forcefully advanced, and rupture occurred within the sheath prior to inflation.Damage to the distal tip of the balloon was observed.The device was removed, and the procedure was completed with another of same device.There were no patient complications as a result of this event, and the patient remained stable post-procedure.It was further reported that the kinked sheath was a non-boston scientific device.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 24758869
• Report Number: 2124215-2026-18019
• Device Sequence Number: 8707740
• Product Code: LIT
• UDI-Device Identifier: 08714729756996
• UDI-Public: (01)08714729756996(17)271114(10)35280946
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141150
• 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): 04/23/2026

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: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0035280946
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 04/23/2026
• Date Device Manufactured: 11/14/2024
• 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