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

Model Number	24700
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.A 6.0mmx40mmx135cm (4f) sterling balloon catheter was advanced for dilation.However, during procedure, it was noted that the balloon burst.There were no any fragments left inside the patient and the device was removed intact.Since the balloon was defective, the physician had to use another device to complete the procedure.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Date of event: used the first day of the month of the bsc aware date since event date was not provided.(b)(6).
Additional Manufacturer Narrative
(b5) describe event or problem: updated to include new information obtained.(b3) date of event: used the first day of the month of the bsc aware date since event date was not provided.(e1) initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.A 6.0mmx40mmx135cm (4f) sterling balloon catheter was advanced for dilation.However, during procedure, it was noted that the balloon burst.There were no any fragments left inside the patient and the device was removed intact.Since the balloon was defective, the physician had to use another device to complete the procedure.There were no patient complications nor injuries reported.It was further reported that the target lesion was located in the lower leg.The device was simply pulled out.

• 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: 16033434
• Report Number: 2124215-2022-54249
• Device Sequence Number: 5477545
• Product Code: DQY
• UDI-Device Identifier: 08714729122784
• UDI-Public: 08714729122784
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2022

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 Expiration Date: 09/22/2025
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0030207858
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2022
• Supplement Date Received by Manufacturer: 12/21/2022
• Initial Report FDA Received Date: 12/22/2022
• Supplement Report FDA Received Date: 12/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2022
• 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
• Patient Sex: Unknown