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	06/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed target lesion was an area of in-stent restenosis (isr) located in the mild tortuous and moderately calcified superficial femoral artery.A 7.0mmx40mmx135cm (4f) fg sterling mr balloon catheter was used to dilate a previously implanted eluvia drug-eluting stent.During the procedure, the balloon ruptured on second inflation at 8 atmospheres for 30 seconds.The device was removed, and the procedure was completed with a different device.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed target lesion was an area of in-stent restenosis (isr) located in the mild tortuous and moderately calcified superficial femoral artery.A 7.0mmx40mmx135cm (4f) fg sterling mr balloon catheter was used to dilate a previously implanted eluvia drug-eluting stent.During the procedure, the balloon ruptured on second inflation at 8 atmospheres for 30 seconds.The device was removed, and the procedure was completed with a different device.There were no patient complications as a result of this event.It was further reported that the device was used as a post-dilation balloon after eluvia placement.

• 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: 22561577
• Report Number: 2124215-2025-48571
• Device Sequence Number: 3904440
• Product Code: DQY
• UDI-Device Identifier: 08714729757443
• UDI-Public: (01)08714729757443(17)280131(10)35757283
• 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,Followup
• Report Date (Section B): 08/22/2025

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: 0035757283
• 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: 06/24/2025
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 08/22/2025
• Date Device Manufactured: 01/31/2025
• 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