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

Model Number	24690
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2 age at time of event: 39 years old and 11 months.
Event or Problem Description
It was reported that shaft break occurred.A 4.0mmx20mmx135cm (4f) sterling balloon catheter was advanced along with a 0.18 guide for right arteriovenous fistula angioplasty.During the procedure, the device was advanced to position in the target site, and then the proximal part of the shaft to the balloon broke.The device was removed using a loop catheter.No complications were reported.
Event or Problem Description
It was reported that shaft break occurred.A 4.0mmx20mmx135cm (4f) sterling balloon catheter was advanced along with a 0.18 guide for right arteriovenous fistula angioplasty.During the procedure, the device was advanced to position in the target site, and then the proximal part of the shaft to the balloon broke.The device was removed using a loop catheter.No complications were reported.
Additional Manufacturer Narrative
A2 age at time of event: 39 years old and 11 months.Upon receipt at our post market quality assurance laboratory, the outer shaft, inner shaft, balloon, and tip were visually and microscopically examined.Visual examination revealed the balloon was in two pieces.The inner shaft was separated and stretched.The stretching was likely caused when removing the balloon.The tip was damaged as well.Microscopic examination revealed the bunching of the shaft and the balloon.Inspection of the remainder of the device presented no other damage or irregularities.

• 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: 19480501
• Report Number: 2124215-2024-33811
• Device Sequence Number: 15200836
• Product Code: DQY
• UDI-Device Identifier: 08714729756958
• UDI-Public: 08714729756958
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2025

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: 09/29/2025
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0030256594
• 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: Not provided
• Supplement Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 06/06/2024
• Supplement Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2022
• 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 Age: 39 YR
• Patient Sex: Male