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

Model Number	24690
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon detachment and removal difficulty occurred.The target lesion was located in the internal carotid artery.A 3.0mmx30mmx135cm (4f) sterling balloon catheter was advanced for dilatation.However, when the device was tried to be removed after inflation and deflation, more resistance was felt than usual, but when it was pulled, the balloon part was separated.The separated part was retrieved with a snare and the procedure was completed.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Device evaluated 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 that the inflation lumen is separated 67.1cm from the hub.The entire proximal end of the device from the hub to the separation is stretched while only the end of the separation at the distal end is stretched.Microscopic examination revealed multiple rub marks on the inflation lumen along the proximal end of the separation.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that balloon detachment and removal difficulty occurred.The target lesion was located in the internal carotid artery.A 3.0mmx30mmx135cm (4f) sterling balloon catheter was advanced for dilatation.However, when the device was tried to be removed after inflation and deflation, more resistance was felt than usual, but when it was pulled, the balloon part was separated.The separated part was retrieved with a snare and the procedure was completed.There were no patient complications nor injuries reported.It was further reported that it was a catheter shaft separation, and the procedure was completed using a non-boston scientific for post dilation.The patient recovered without problem.

• 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: 16444648
• Report Number: 2124215-2023-08681
• Device Sequence Number: 17542843
• Product Code: DQY
• UDI-Device Identifier: 08714729756873
• UDI-Public: 08714729756873
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2023

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 Expiration Date: 09/11/2025
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0030126257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2023
• Supplement Date Received by Manufacturer: 03/06/2023
• Initial Report FDA Received Date: 02/27/2023
• Supplement Report FDA Received Date: 03/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2022
• 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: Required Intervention
• Patient Sex: Unknown