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

Model Number 24700

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular Dissection (3160)

Event Date 04/06/2021

Event Type  Injury  

Event 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
• Type of Device: 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11725462
• MDR Text Key: 247302771
• Report Number: 2134265-2021-05035
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08714729122906
• UDI-Public: 08714729122906
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K053116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other