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

Model Number	24700
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break occurred requiring surgical intervention.The patient underwent a limiting flow procedure.A 4x80 sterling balloon catheter was advanced for dilation of a venous system in the leg.No resistance was felt during withdrawal.However, when the balloon catheter was removed from the sheath, it was noted that the shaft had fractured or broken off in the patient's foot and a cutdown was performed to retrieve the fragment.The patient status was ok.No patient complications were reported due to this event.
Additional Manufacturer Narrative
Detailed product information was not provided to bsc as the account did not have the available information.Because the product lot number is unknown, we are unable to provide the complete unique identifier (udi) #.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a sterling balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed a separation to the guidewire lumen 12.4cm from the tip.The balloon is separated 2.8cm from the tip.Microscopic examination revealed no additional damages.The proximal section of the separation did not return.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found that the balloon and guidewire lumen is separated.Detailed product information was not provided to bsc as the account did not have the available information.Because the product lot number is unknown, we are unable to provide the complete unique identifier (udi) #.
Event or Problem Description
It was reported that shaft break occurred requiring surgical intervention.The patient underwent a limiting flow procedure.A 4x80 sterling balloon catheter was advanced for dilation of a venous system in the leg.No resistance was felt during withdrawal.However, when the balloon catheter was removed from the sheath, it was noted that the shaft had fractured or broken off in the patient's foot and a cutdown was performed to retrieve the fragment.The patient status was ok.No patient complications were reported due to this event.

• 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: 22686091
• Report Number: 2124215-2025-50389
• Device Sequence Number: 15814406
• Product Code: DQY
• UDI-Device Identifier: 08714729123668
• UDI-Public: (01)08714729123668
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2025

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 Model Number: 24700
• Device Catalogue Number: 24700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown