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

Model Number	24690
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Embolism/Embolus (4438)
Date of Event	07/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that embolism occurred and the patient experienced cerebral vascular accident.The patient underwent left carotid angioplasty.After crossing the lesion with a hydrophilic guidewire, a non-boston scientific stent was implanted followed by post-dilatation with a 6.0mmx20mmx135cm (4f) sterling balloon catheter.The patient was assessed neurologically and exhibited deficits in speech and consciousness.Cerebral pan angiography was performed which revealed an occlusion at the middle cerebral artery due to possible embolism.Thrombolytic treatment was then started and the patient recovered part of mobility and speech after one hour.No further complications were reported and the patient was fully recovered.

• 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: 15195229
• Report Number: 2124215-2022-27955
• Device Sequence Number: 5602985
• Product Code: DQY
• UDI-Device Identifier: 08714729757252
• UDI-Public: 08714729757252
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/09/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/13/2024
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0026625578
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2022
• Initial Report FDA Received Date: 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 62 KG