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

Model Number	24700
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a balloon rupture occurred, requiring the shaft of the balloon to be cut for removal.The target lesion was located in the peripheral artery.A 7.0mmx40mmx135cm (4f) sterling balloon catheter was advanced for dilation.During the procedure, the balloon was inflated to nominal pressure.The device was then inflated a second time to nominal pressure; however, when attempting to remove pressure, the balloon burst.No fragmentation occurred.When attempting to pull back through the sheath, resistance was felt.The balloon was unable to fully deflate due to the rupture.The physician had to cut the shaft of the balloon to let pressure trickle out to be able to remove balloon from the sheath.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 balloon catheter was returned to our post market quality assurance laboratory.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the inflation lumen is separated 27.1cm from the tip.The guidewire lumen is separated 27.6cm from the tip.There are multiple stretching along the shaft.Microscopic examination revealed a pinhole 36mm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there is damage to the device.
Event or Problem Description
It was reported that a balloon rupture occurred, requiring the shaft of the balloon to be cut for removal.The target lesion was located in the peripheral artery.A 7.0mmx40mmx135cm (4f) sterling balloon catheter was advanced for dilation.During the procedure, the balloon was inflated to nominal pressure.The device was then inflated a second time to nominal pressure; however, when attempting to remove pressure, the balloon burst.No fragmentation occurred.When attempting to pull back through the sheath, resistance was felt.The balloon was unable to fully deflate due to the rupture.The physician had to cut the shaft of the balloon to let pressure trickle out to be able to remove balloon from the sheath.The procedure was completed with another of the same device.There were no patient complications as a result of this event.

• 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: 23639455
• Report Number: 2124215-2025-84319
• Device Sequence Number: 15813517
• Product Code: LIT
• UDI-Device Identifier: 08714729124078
• UDI-Public: (01)08714729124078(17)280521(10)36587739
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K053116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0036587739
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown