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

Model Number	24700
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter city: (b)(6).
Event or Problem Description
It was reported that procedure was cancelled.The 100% stenosed target lesion was located in the moderately tortuous and severely left forearm vein.A 5.0mmx40mmx40cm sterling balloon catheter was advanced for dilation.During the procedure, the device could not cross the lesion.The device was not completed due to same device unavailable.No complications were reported, and the patient was in good condition after the procedure.
Event or Problem Description
It was reported that procedure was cancelled.The 100% stenosed target lesion was located in the moderately tortuous and severely left forearm vein.A 5.0mmx40mmx40cm sterling balloon catheter was advanced for dilation.During the procedure, the device could not cross the lesion.The device was not completed due to same device unavailable.No complications were reported, and the patient was in good condition after the procedure.It was further reported that the patient was sedated with local anesthesia when the issue occurred, and the procedure was completed with the device.
Additional Manufacturer Narrative
E1: initial reporter city: (b)(6).

• 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: 19802204
• Report Number: 2124215-2024-44162
• Device Sequence Number: 7395235
• Product Code: DQY
• UDI-Device Identifier: 08714729122913
• UDI-Public: 08714729122913
• 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): 08/13/2024

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 Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0033090812
• 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: 06/25/2024
• Supplement Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 08/13/2024
• Date Device Manufactured: 12/19/2023
• 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: Unknown