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

Model Number	24690
Medical Device Problem Codes	Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon damage occurred.A 4.0mmx20mmx135cm (4f) sterling balloon catheter was selected for a stenting procedure in the carotid artery.During preparation, the balloon was found to be damaged.Another of the same device was used to complete the procedure.No complications reported, and patient status was stable.
Additional Manufacturer Narrative
B5.Describe event or problem: was updated per the additional information provided.Device evaluated by mfr: the device was returned for analysis.The outer shaft, inner shaft, balloon, and tip were visually and microscopically examined.Visual examination showed tip damage.Inspection of the remainder of the device presented no other damage or irregularities.Functional testing was completed by inserting a guidewire through the port, while inserting the guidewire it got stuck on some dry blood but was pushed out and the guidewire was placed with not issues.
Event or Problem Description
It was reported that balloon damage occurred.A 4.0mmx20mmx135cm (4f) sterling balloon catheter was selected for a stenting procedure in the carotid artery.During preparation, the balloon was found to be damaged.Another of the same device was used to complete the procedure.No complications reported, and patient status was stable.It was further reported that the issue was with the guidewire as it could not enter the balloon catheter.
Event or Problem Description
It was reported that balloon damage occurred.A 4.0mmx20mmx135cm (4f) sterling balloon catheter was selected for a stenting procedure in the carotid artery.During preparation, the balloon was found to be damaged.Another of the same device was used to complete the procedure.No complications reported, and patient status was stable.It was further reported that the issue was with the guidewire as it could not enter the balloon catheter.
Additional Manufacturer Narrative
B5.Describe event or problem: was updated per the additional information provided.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20279878
• Report Number: 2124215-2024-58922
• Device Sequence Number: 7415078
• Product Code: DQY
• UDI-Device Identifier: 08714729756958
• UDI-Public: 08714729756958
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0033477810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2024
• Supplement Date Received by Manufacturer: 09/23/2024; 10/18/2024
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 10/16/2024; 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2024
• 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
• Patient Sex: Female