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	07/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon rupture occurred.The 99% stenosed target lesion was located in the severely tortuous and severely calcified in the right superficial femoral artery (sfa).A 7.0mmx40mmx135cm (4f) sterling balloon was advanced for dilation.However, during the first inflation shortly before nominal pressure for 15 seconds, the balloon ruptured.Even when it was removed from the body and expanded, no pressure was generated, and a pinhole-like spot at the tip could be visually confirmed.Although there was calcification in the lesion, there was no snagging or other effect on balloon insertion.The device was removed without any problem and the procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.E1 - initial reporter address 1: (b)(6).

• 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: 22581216
• Report Number: 2124215-2025-49475
• Device Sequence Number: 8064579
• Product Code: DQY
• UDI-Device Identifier: 08714729757443
• UDI-Public: (01)08714729757443(17)280203(10)35764539
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 07/23/2025

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: 0035764539
• 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: 07/18/2025
• Initial Report FDA Received Date: 07/23/2025
• Date Device Manufactured: 02/03/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: STENT - ELUVIA
• Patient Sex: Unknown