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

Model Number	24700
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the balloon ruptured, and the tip was detached, requiring intervention.The occluded target lesion was located in the severely tortuous and severely calcified left renal artery.A 6.0mmx40mmx135cm (4f) sterling balloon catheter was advanced and inflated; however, the balloon ruptured upon initial inflation at 18 atmospheres for 20 seconds.The catheter was removed from the patient and found the tip was missing.A second wire and another balloon were used to capture the detached piece.The procedure was completed using an alternate device.No complications were reported, and the patient was fully recovered.
Event or Problem Description
It was reported that the balloon ruptured, and the tip was detached, requiring intervention.The occluded target lesion was located in the severely tortuous and severely calcified left renal artery.A 6.0mmx40mmx135cm (4f) sterling balloon catheter was advanced and inflated; however, the balloon ruptured upon initial inflation at 18 atmospheres for 20 seconds.The catheter was removed from the patient and found the tip was missing.A second wire and another balloon were used to capture the detached piece.The procedure was completed using an alternate device.No complications were reported, and the patient was fully recovered.It was further reported via user facility#: (b)(4), that the vascular access was obtained via left radial artery.However, the left brachial artery was highly tortuous.The physician decided to pursue left femoral artery access by placing 6f sheath and 6f steerable sheath.The lesion was wired with non-boston scientific (bsc) guidewire and dilated with 2mm, 3mm and 5mm non-bsc balloon for 200 pulses.After this 6mm sterling balloon ruptured, the sheath and balloon were removed intact and reinserted.The lesion was wired again with 6mm athletis balloon, but it did not cross.The ivus shows residual severe underexpansion.A 6mm nc coronary balloon was used but ruptured, therefore a 6mm drug-coated balloon was used to dilate but still residual waist was noted.

• 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: 21266138
• Report Number: 2124215-2025-01266
• Device Sequence Number: 8606196
• Product Code: DQY
• UDI-Device Identifier: 08714729122784
• UDI-Public: 08714729122784
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/28/2026
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0031924702
• 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: 12/31/2024
• Supplement Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 03/06/2025
• Date Device Manufactured: 06/29/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female