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

Model Number	24690
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sterling balloon catheter was received for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a pinhole 8mm from the tip.Functional testing was performed by inflating the device and the only leak found was coming from the pinhole.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis could not confirm the leak at the hub.
Event or Problem Description
Reportable based on device analysis completed on 15mar2024.It was reported that balloon hub leak occurred.The patient was presented for carotid artery stenting.A 3.0mmx40mmx135cm (4f) sterling balloon catheter was advanced for dilatation.However, during inflation, it was confirmed that the balloon hub was leaking, and the balloon was unable to expand.The procedure was completed with another of same device.There were no complications reported and the patient condition was good.However, returned device analysis revealed a pinhole 8mm from the tip.

• 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: 19052994
• Report Number: 2124215-2024-20709
• Device Sequence Number: 7069516
• Product Code: DQY
• UDI-Device Identifier: 08714729756880
• UDI-Public: 08714729756880
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 04/05/2024

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: 08/15/2026
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0032224453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2024
• Initial Report FDA Received Date: 04/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2023
• 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