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

Model Number	24690
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.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 rupture at 9cm from the tip.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 08oct2025.It was reported that balloon leak occurred.The target lesion was located in the thoracic aorta and subclavian artery.A 6.0mmx20mmx135cm (4f) sterling balloon catheter was selected for use in a thoracic aortic stent-graft implantation (branch revascularization).During the procedure, a boston scientific pressure pump was used to inject contrast agent into a balloon to pre-dilate the stent.Under balloon angiography, there was an obvious manifestation of contrast agent leakage.The procedure was completed with another of same device.There were no patient complications as a result of this event.However, device analysis revealed a rupture at 9cm from the tip.
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).E1 - initial reporter email: added device evaluated by mfr: the device was returned for evaluation.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 rupture at 9cm from the tip.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 08oct2025.It was reported that balloon leak occurred.The target lesion was located in the thoracic aorta and subclavian artery.A 6.0mmx20mmx135cm (4f) sterling balloon catheter was selected for use in a thoracic aortic stent-graft implantation (branch revascularization).During the procedure, a boston scientific pressure pump was used to inject contrast agent into a balloon to pre-dilate the stent.Under balloon angiography, there was an obvious manifestation of contrast agent leakage.The procedure was completed with another of same device.There were no patient complications as a result of this event.However, device analysis revealed a rupture at 9cm 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: 23450035
• Report Number: 2124215-2025-78430
• Device Sequence Number: 8056584
• Product Code: DQY
• UDI-Device Identifier: 08714729757252
• UDI-Public: (01)08714729757252(17)270617(10)34251443
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K141150
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2026

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 Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0034251443
• 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: 10/08/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2024
• 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: 75 YR
• Patient Sex: Female
• Patient Weight: 60 KG