MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING MONORAIL PTA BALLOON DILATATION CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Lot Number	0035780173
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 70%-90% stenosed target lesion was located in the moderately tortuous and severely calcium mid to distal superficial femoral artery (sfa).A 5.0 x 150 mm 200cm sterling monorail pta balloon dilatation catheter was advanced for treatment.During the procedure, when the balloon was advance to distal sfa, the balloon ruptured upon inflation at 10 atmospheres for 60 seconds.The balloon was then pulled back to the mid sfa, however the balloon was ruptured again for 30 seconds.The device was removed without any problem, and the procedure was completed with a non-bsc device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
A global sterling mr 5.0 x 150 mm 200cm was returned to the complaint investigation site (cis) for analysis.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 pinhole 45mm from the tip causing the balloon to leak.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that balloon rupture occurred.The 70%-90% stenosed target lesion was located in the moderately tortuous and severely calcuim mid to distal superficial femoral artery (sfa).A 5.0 x 150 mm 200cm sterling monorail pta balloon dilatation catheter was advanced for treatment.During the procedure, when the balloon was advance to distal sfa, the balloon ruptured upon inflation at 10 atmospheres for 60 seconds.The balloon was then pulled back to the mid sfa, however the balloon was ruptured again for 30 seconds.The device was removed without any problem, and the procedure was completed with a non-bsc device.There were no patient complications as a result of this event.

• Brand Name: STERLING MONORAIL PTA BALLOON DILATATION CATHETER
• 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: 21989768
• Report Number: 2124215-2025-29634
• Device Sequence Number: 15531993
• Product Code: LIT
• UDI-Device Identifier: 00191506046453
• UDI-Public: (01)00191506046453
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• 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): 06/10/2025

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 Lot Number: 0035780173
• 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: 04/14/2025
• Supplement Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2025
• 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