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

Model Number	24700
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete udi and other product specific information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous and moderately calcified superficial femoral artery - vessel below the knee.A 4.0mmx40mmx135cm (4f) sterling otw balloon catheter was advanced for dilatation.However, during the initial inflation, the balloon ruptured when it reached 6 atmospheres.The device was removed, and the procedure was completed with a different device.There were no patient injuries reported, and the patient condition was good post-procedure.
Event or Problem Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous and moderately calcified superficial femoral artery - vessel below the knee.A 4.0mmx40mmx135cm (4f) sterling otw balloon catheter was advanced for dilatation.However, during the initial inflation, the balloon ruptured when it reached 6 atmospheres.The device was removed, and the procedure was completed with a different device.There were no patient injuries reported, and the patient condition was good post-procedure.

• 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: 21727060
• Report Number: 2124215-2025-19453
• Device Sequence Number: 3783702
• Product Code: DQY
• UDI-Device Identifier: 08714729123576
• UDI-Public: (01)08714729123576(17)260606(10)31773892
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2025

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 Expiration Date: 06/06/2026
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0031773892
• 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: 03/07/2025
• Supplement Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 05/07/2025
• Date Device Manufactured: 06/07/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BALLOON CATHETER USED: SHIDEN, PCB; BALLOON CATHETER USED: SHIDEN, PCB; GUIDE CATHETER USED: NONE; GUIDE CATHETER USED: NONE; GUIDEWIRE USED: CROSSLEAD, JUPITER 15; GUIDEWIRE USED: CROSSLEAD, JUPITER 15; INTRODUCER SHEATH USED: PARENT SELECT; INTRODUCER SHEATH USED: PARENT SELECT; MICRO CATHETER: PROMANENT; MICRO CATHETER: PROMANENT; STENT USED: ELUVIA; STENT USED: ELUVIA
• Patient Sex: Unknown