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

Model Number	24690
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Codes	Air Embolism (1697); Stroke/CVA (1770)
Date of Event	10/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a balloon leak caused an air embolism, which led to a patient stroke.The 50% stenosed target lesion was located in the non-tortuous and moderately calcified carotid artery.A 6.0mmx30mmx135cm (4f) sterling balloon catheter was used to pre-dilate a non-boston scientific stent.However, the physician noticed a leak in the balloon as it could not inflate.After trying to inflate the balloon twice, the air in the balloon leaked out causing a stroke to the patient due to the air embolism.The procedure was not completed, and the patient was transferred to a stroke unit at another hospital.No further complications were reported, and the patient is expected to fully recover.
Additional Manufacturer Narrative
Device evaluation by manufacturer: 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 hole to the guidewire lumen 43mm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there is a hole in the guidewire lumen.
Event or Problem Description
It was reported that a balloon leak caused an air embolism, which led to a patient stroke.The 50% stenosed target lesion was located in the non-tortuous and moderately calcified carotid artery.A 6.0mmx30mmx135cm (4f) sterling balloon catheter was used to pre-dilate a non-boston scientific stent.However, the physician noticed a leak in the balloon as it could not inflate.After trying to inflate the balloon twice, the air in the balloon leaked out causing a stroke to the patient due to the air embolism.The procedure was not completed, and the patient was transferred to a stroke unit at another hospital.No further complications were reported, and the patient is expected to fully recover.It was further reported that the balloon had been flushed to remove the air prior to use, but it was not inflated prior to use.The device was inflated using a mixture of saline and contrast medium and a normal inflation device.After the balloon was inflated to only a few atmospheres, the physician noticed a hole in the balloon.Prior to the procedure, the patient status was stable, but during the procedure using computerized tomography, the air embolism was confirmed.The patient had recovered after being transferred to another hospital.

• 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: 20494658
• Report Number: 2124215-2024-63375
• Device Sequence Number: 3554186
• Product Code: DQY
• UDI-Device Identifier: 08714729757276
• UDI-Public: 08714729757276
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0034329660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2024
• Supplement Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown