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

Model Number	24700
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	04/06/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that vessel dissection occurred.The stenosed target lesion was located in the popliteal artery.Following dilatation with a non-bsc balloon catheter, a 5.0mmx40mmx135cm sterling balloon catheter was selected for use; however, dissection occurred.The physician stated that dissection was due to the angioplasty procedure.The procedure was completed with the original device.The patient was expected to fully recover and was discharged from the hospital.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11725462
• Report Number: 2134265-2021-05035
• Device Sequence Number: 3946071
• Product Code: DQY
• UDI-Device Identifier: 08714729122906
• UDI-Public: 08714729122906
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K053116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/26/2021

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: 05/22/2023
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0025532117
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2021
• Initial Report FDA Received Date: 04/26/2021
• 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: Other