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

Model Number	24690
Medical Device Problem Codes	Inflation Problem (1310); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient was age over 18.E1: initial reporter facility name: (b)(6) hospital.Device evaluated by mfr: the device was returned for analysis and underwent a visual and microscopic examination on the outer shaft, inner shaft, balloon, and tip.Visual examination revealed a separation at the tip and hypotube.The tip, hub, strain relief, and proximal section of the hypotube is missing.The returned piece measures approximately 149.6cm long.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found that the shaft and tip is separated.
Event or Problem Description
Reportable based on device analysis completed on 23-oct-2024.It was reported that balloon failure to inflate occurred.The 80% stenosed target lesion was located in the mildly tortuous and moderately calcified carotid artery.A 3.0mmx30mmx135cm sterling balloon catheter was advanced for dilatation.During the procedure, after multiple inflation attempts at normal atmospheric pressure, the balloon would not inflate.There was no pinhole, leak, or tear noted on the balloon.The procedure was completed with another of the same device.There were no patient complications reported, and the patient status was stable post procedure.However, device analysis revealed a hypotube and tip separation.

• 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: 20693332
• Report Number: 2124215-2024-70635
• Device Sequence Number: 18288776
• Product Code: DQY
• UDI-Device Identifier: 08714729756873
• UDI-Public: 08714729756873
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K141150
• 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
• Report Date (Section B): 11/15/2024

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: 08/13/2026
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0032207849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2023
• 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: Male