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

Model Number	24700
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon rupture occurred.The stenosed target lesion was located in the thoracic aorta.A 5.0mmx100mmx135cm sterling balloon catheter was advanced for dilatation.During the procedure, the balloon was ruptured.The procedure was completed with another of the same device.There were no patient complication reported.
Event or Problem Description
It was reported that the balloon rupture occurred.The stenosed target lesion was located in the thoracic aorta.A 5.0mmx100mmx135cm sterling balloon catheter was advanced for dilatation.During the procedure, the balloon was ruptured.The procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.The device was returned for evaluation.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a longitudinal tear in the balloon 28mm from the tip and is approximately 32mm long.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that the balloon rupture occurred.The stenosed target lesion was located in the thoracic aorta.A 5.0 mm x 100 mm x 135 cm sterling balloon catheter was advanced for dilatation.During the procedure, the balloon was ruptured.The procedure was completed with another of the same device.There were no patient complications reported.It was further reported that target lesion was 75% stenosed, moderately tortuous and non-calcified.
Additional Manufacturer Narrative
A2: age at time of event: 18 years or older.B5: describe event or problem: added information, based on additional information: the device was returned for evaluation.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a longitudinal tear in the balloon 28 mm from the tip and is approximately 32 mm long.Inspection of the remainder of the device presented no other damage or irregularities.

• 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: 20650290
• Report Number: 2124215-2024-70634
• Device Sequence Number: 19611492
• Product Code: DQY
• UDI-Device Identifier: 08714729122814
• UDI-Public: 08714729122814
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/10/2025

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 Expiration Date: 07/25/2026
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0032092999
• 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: 10/22/2024
• Supplement Date Received by Manufacturer: 11/26/2024; 12/23/2024
• Initial Report FDA Received Date: 11/11/2024
• Supplement Report FDA Received Date: 12/10/2024; 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2023
• 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
• Patient Sex: Female