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	Foreign Body In Patient (2687)
Date of Event	08/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture occurred, and a portion remains inside the patient.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified left subclavian vein.A 10.0mmx40mmx80cm (5f) sterling balloon catheter was advanced for dilation.During pressurization on the first inflation, the balloon ruptured.The device was successfully removed, and it appears to have no issues, but there is concern that it may have been damaged, and a portion remains inside the patient's body.The procedure was completed with a different device.No complications reported, and patient status was good.
Additional Manufacturer Narrative
The device was returned for analysis and the evaluation was completed on 18sep2024.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.The visual examination revealed that the guidewire lumen is separated 79cm from the hub.The balloon is separated 85cm from the hub.There is a piece of separated balloon that measures approximately 28mm long.Microscopic examination revealed no additional damages.The distal end of the separated guidewire lumen, distal end of the separated balloon, marker band, and tip did not return for analysis.
Event or Problem Description
It was reported that balloon rupture occurred, and a portion remains inside the patient.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified left subclavian vein.A 10.0mmx40mmx80cm (5f) sterling balloon catheter was advanced for dilation.During pressurization on the first inflation, the balloon ruptured.The device was successfully removed, and it appears to have no issues, but there is concern that it may have been damaged, and a portion remains inside the patient's body.The procedure was completed with a different device.No complications reported, and patient status was good.

• 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: 20128973
• Report Number: 2124215-2024-54646
• Device Sequence Number: 11579608
• Product Code: DQY
• UDI-Device Identifier: 08714729123453
• UDI-Public: 08714729123453
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 10/10/2024

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: 06/14/2026
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0031830362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2023
• 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: Other
• Patient Sex: Unknown