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

Model Number	24700
Medical Device Problem Codes	Fracture (1260); Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture, balloon detachment and shaft break occurred.A 6.0mmx100mmx80cm-hybrid sterling balloon catheter was advanced for dilation.However, during inflation, the balloon ruptured.The balloon was deflated prior to removal attempt.The physician tried to remove the device but noticed that the distal tip portion of the balloon remained in the patient at the point of the lesion along with the radiopaque marker band.The physician attempted to remove the detached portion but was unsuccessful.The detached balloon was pinned to the vessel wall with a stent and the rest of the device was removed fine.No patient complications were reported.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14417356
• Report Number: 2134265-2022-05535
• Device Sequence Number: 17544678
• Product Code: DQY
• UDI-Device Identifier: 08714729123699
• UDI-Public: 08714729123699
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/16/2022

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: 01/11/2025
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0028665777
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 05/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2022
• 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