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

Model Number	24715
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a shaft break occurred.A 5.0mmx150mmx150cm sterling balloon catheter was advanced for dilatation.During the procedure, the device became detached from the shaft, resulting in the formation of a halo-like ring in the center of the balloon.The procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
Correction h1: from serious injury to malfunction.
Event or Problem Description
It was reported that a shaft break occurred.A 5.0mmx150mmx150cm sterling balloon catheter was advanced for dilatation.During the procedure, the device became detached from the shaft, resulting in the formation of a halo-like ring in the center of the balloon.The procedure was completed with another of the same device.There were no patient complications reported.

• 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: 20495604
• Report Number: 2124215-2024-65441
• Device Sequence Number: 3601284
• Product Code: LIT
• UDI-Device Identifier: 08714729845362
• UDI-Public: 08714729845362
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K132430
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2024

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: 07/19/2025
• Device Model Number: 24715
• Device Catalogue Number: 24715
• Device Lot Number: 0029802074
• 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: 09/23/2024
• Supplement Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 10/30/2024
• Date Device Manufactured: 07/20/2022
• 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