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

Model Number	H74939031403010
Medical Device Problem Codes	Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter phone:(b)(6).
Event or Problem Description
It was reported that the device was leaking.The more than 90% stenosed target lesion was located in the internal carotid artery.After an ez filter wire was placed 2cm at the distal end of the lesion, a 4.0mmx30mmx135cm sterling balloon catheter was advanced for dilatation.However, during the procedure, it was noticed to be leaking gas.A new 4x30 sterling balloon catheter was placed along the filter guidewire to performed dilation.After pre-dilatation, a 7x40 wallstent stent was placed, and the procedure was completed.No patient complications were reported, and the patient was stable.
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).Device evaluated by mfr: returned product consisted of a sterling balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a pinhole in the balloon 15mm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there is a pinhole in the balloon.
Event or Problem Description
It was reported that the device was leaking.The more than 90% stenosed target lesion was located in the internal carotid artery.After an ez filter wire was placed 2cm at the distal end of the lesion, a 4.0mmx30mmx135cm sterling balloon catheter was advanced for dilatation.However, during the procedure, it was noticed to be leaking gas.A new 4x30 sterling balloon catheter was placed along the filter guidewire to performed dilation.After pre-dilatation, a 7x40 wallstent stent was placed, and the procedure was completed.No patient complications were reported, and the patient was stable.
Event or Problem Description
It was reported that the device was leaking.The more than 90% stenosed target lesion was located in the internal carotid artery.After an ez filter wire was placed 2cm at the distal end of the lesion, a 4.0mmx30mmx135cm sterling balloon catheter was advanced for dilatation.However, during the procedure, it was noticed to be leaking gas.A new 4x30 sterling balloon catheter was placed along the filter guidewire to performed dilation.After pre-dilatation, a 7x40 wallstent stent was placed, and the procedure was completed.No patient complications were reported, and the patient was stable.
Additional Manufacturer Narrative
This report is being filed to correct the model number and unique identifier (udi) # in response to an fda request.E1: initial reporter phone: (b)(6).Device evaluated by mfr: returned product consisted of a sterling balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a pinhole in the balloon 15mm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there is a pinhole in the balloon.

• 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: 17867971
• Report Number: 2124215-2023-50893
• Device Sequence Number: 7490575
• Product Code: DQY
• UDI-Device Identifier: 08714729756972
• UDI-Public: (01)08714729756972(17)260314(10)31237906
• 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,Followup,Followup
• Report Date (Section B): 07/02/2024

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: 03/14/2026
• Device Model Number: H74939031403010
• Device Catalogue Number: 24690
• Device Lot Number: 0031237906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/06/2023
• Supplement Date Received by Manufacturer: 10/27/2023; 06/12/2024
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 11/10/2023; 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2023
• 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 Age: 51 YR
• Patient Sex: Male
• Patient Weight: 80 KG