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

Model Number	24690
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 91% stenosed target lesion was located in the moderately tortuous and severely calcified c1.A 3.0mmx30mmx135cm sterling balloon was selected for use in a percutaneous carotid artery stenting.During the first inflation at 10 atmospheres for five seconds, the balloon burst.The device was removed with guide catheter and the procedure was completed with another of the same device.There was no patient injury as a result of this event.
Additional Manufacturer Narrative
E1 - initial reporter phone:(b)(6).
Additional Manufacturer Narrative
Updated d4: lot number.Updated d4: expiration date.E1 - initial reporter phone: (b)(6).Updated h4: device manufacture date.
Event or Problem Description
It was reported that balloon rupture occurred.The 91% stenosed target lesion was located in the moderately tortuous and severely calcified c1.A 3.0mmx30mmx135cm sterling balloon was selected for use in a percutaneous carotid artery stenting.During the first inflation at 10 atmospheres for five seconds, the balloon burst.The device was removed with guide catheter and the procedure was completed with another of the same device.There was no patient injury as a result of this event.
Additional Manufacturer Narrative
A1 - patient identifier: added.A2 - age at time of event: added.A4 - weight: added.(b)(6).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 revealed no damages.Microscopic examination revealed a longitudinal tear in the balloon 5mm from the tip and is approximately 19mm long.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The 91% stenosed target lesion was located in the moderately tortuous and severely calcified c1.A 3.0mmx30mmx135cm sterling balloon was selected for use in a percutaneous carotid artery stenting.During the first inflation at 10 atmospheres for five seconds, the balloon burst.The device was removed with guide catheter and the procedure was completed with another of the same device.There was no patient injury as a result of this event.
Event or Problem Description
It was reported that balloon rupture occurred.The 91% stenosed target lesion was located in the moderately tortuous and severely calcified c1.A 3.0mmx30mmx135cm sterling balloon was selected for use in a percutaneous carotid artery stenting.During the first inflation at 10 atmospheres for five seconds, the balloon burst.The device was removed with guide catheter and the procedure was completed with another of the same device.There was no patient injury as a result of this event.
Additional Manufacturer Narrative
Updated d4: lot number.Updated d4: expiration date.E1 - initial reporter phone: (b)(6).Updated h4: device manufacture date.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 revealed no damages.Microscopic examination revealed a longitudinal tear in the balloon 5mm from the tip and is approximately 19mm long.No other issues were identified during the product analysis.

• 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: 22804309
• Report Number: 2124215-2025-56438
• Device Sequence Number: 8950810
• Product Code: LIT
• UDI-Device Identifier: 08714729756873
• UDI-Public: (01)08714729756873(17)270812(10)34621517
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup,Followup
• Report Date (Section B): 11/18/2025

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: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0034338973
• 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: 07/25/2025
• Supplement Date Received by Manufacturer: 09/07/2025; 10/06/2025; 11/03/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 09/29/2025; 10/28/2025; 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2024
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 72 KG