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	Hemorrhage/Blood Loss/Bleeding (1888); Perforation of Vessels (2135)
Date of Event	12/02/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that vessel perforation occurred.The 99% stenosed target lesion was located in the severely tortuous and non-calcified internal carotid artery.A bsc filterwire was placed in position and the lesion was pre-dilated with a sterling balloon.A 8.0-29 carotid wallstent was the advanced to the lesion.The device had difficulties in crossing but eventually crossed and the stent was placed without further problems.Subsequently, the lumen was viewed with an opticross 18 imaging catheter and post-dilatation using a 6.0mmx30mmx135cm sterling balloon catheter.Bleeding was observed from the center of the stent.Protamine was injected, dilatation using a 6mm balloon was performed, and the neck region was compressed to stop the bleeding and the procedure was completed.The patient left the operating room without symptoms.Physician commented that the bleeding might have been caused by the stent getting caught while passing through the stenosis.No further patient complications were reported.
Event or Problem Description
It was reported that vessel perforation occurred.The 99% stenosed target lesion was located in the severely tortuous and non-calcified internal carotid artery.A bsc filterwire was placed in position and the lesion was pre-dilated with a sterling balloon.A 8.0-29 carotid wallstent was the advanced to the lesion.The device had difficulties in crossing but eventually crossed and the stent was placed without further problems.Subsequently, the lumen was viewed with an opticross 18 imaging catheter and post-dilatation using a 6.0mm x 30mm x 135cm sterling balloon catheter.Bleeding was observed from the center of the stent.Protamine was injected, dilatation using a 6mm balloon was performed, and the neck region was compressed to stop the bleeding and the procedure was completed.The patient left the operating room without symptoms.Physician commented that the bleeding might have been caused by the stent getting caught while passing through the stenosis.No further patient complications were reported.It was further reported that vessel perforation was not reported.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11066220
• Report Number: 2134265-2020-18306
• Device Sequence Number: 2691707
• Product Code: DQY
• UDI-Device Identifier: 08714729757276
• UDI-Public: 08714729757276
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141150
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2021

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: 12/05/2022
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0024884563
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/03/2020
• Supplement Date Received by Manufacturer: 12/23/2020
• Initial Report FDA Received Date: 12/23/2020
• Supplement Report FDA Received Date: 01/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention