MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING SL; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	H74939148401510
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon deflation issue occurred.The 80% stenosed target lesion was located in a mildly tortuous and mildly calcified vessel.A 4.0mm x 150mm x 150cm sterling sl balloon catheter with a saline-contrast ratio of 70/30 was advanced for dilation.The balloon was inflated at 6 atmospheres per minute.Upon deflation, it was noted that the balloon was very slow to deflate and hard to remove.The physician waited for a few minutes for the balloon to deflate and was removed intact from the patient.The procedure was completed using this device.There were no patient complications as a result of this event.

• Brand Name: STERLING SL
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• 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: 22170072
• Report Number: 2124215-2025-36796
• Device Sequence Number: 7957567
• Product Code: DQY
• UDI-Device Identifier: 08714729782384
• UDI-Public: (01)08714729782384(17)270102(10)35545740
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K093720
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/09/2025

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: H74939148401510
• Device Catalogue Number: H74939148401510
• Device Lot Number: 0035545740
• 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: 05/14/2025
• Initial Report FDA Received Date: 06/09/2025
• Date Device Manufactured: 01/02/2025
• 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
• Patient Sex: Unknown