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	12/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that failure in maintaining pressure occurred.The patient was presented with carotid artery stenosis and underwent intracranial angiography and balloon dilatation.The 99% stenosed target lesion was located in mildly tortuous and severely calcified carotid artery.A 7.0mmx30mmx135cm (4f) sterling balloon catheter was advanced for pre-dilation.The device was initially inflated for 15 seconds; however, the balloon kept leaking gas and could not hold pressure even after multiple attempts.The device was removed, and the procedure was completed with another of same device.There were no patient complications nor injuries reported and the patient was stable after the procedure.
Additional Manufacturer Narrative
Device evaluated mfr.: returned product consisted of a sterling balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual and microscopic examination revealed no damages.Functional testing was performed by inflating the device to rated burst pressure and it was able to hold pressure.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis could not confirm the reported leak.
Event or Problem Description
It was reported that failure in maintaining pressure occurred.The patient was presented with carotid artery stenosis and underwent intracranial angiography and balloon dilatation.The 99% stenosed target lesion was located in mildly tortuous and severely calcified carotid artery.A 7.0mmx30mmx135cm (4f) sterling balloon catheter was advanced for pre-dilation.The device was initially inflated for 15 seconds; however, the balloon kept leaking gas and could not hold pressure even after multiple attempts.The device was removed, and the procedure was completed with another of same device.There were no patient complications nor injuries reported and the patient was stable after the procedure.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16218104
• Report Number: 2124215-2022-56566
• Device Sequence Number: 7455632
• Product Code: DQY
• UDI-Device Identifier: 08714729757566
• UDI-Public: 08714729757566
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2023

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: 06/30/2024
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0027592891
• 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: 12/28/2022
• Supplement Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 01/20/2023
• Supplement Report FDA Received Date: 03/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2021
• 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: 59 YR
• Patient Sex: Male
• Patient Weight: 65 KG