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

Model Number	H74939031554080
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
When bringing open supplies to procedure, it was noted the balloon was bent.Medical doctor decline to utilized it.

• Brand Name: STERLING¿
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple MN 55311
• MDR Report Key: 20694084
• Report Number: 20694084
• Device Sequence Number: 15313675
• Product Code: DQY
• UDI-Device Identifier: 08714729757221
• UDI-Public: (01)08714729757221(17)250929(10)30255558
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/25/2024
• Report Date (Section F): 10/25/2024

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
• Device Model Number: H74939031554080
• Device Catalogue Number: H74939031554080
• Device Lot Number: 30255558
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/15/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/15/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Date Report Sent to FDA: 10/25/2024