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	03/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used the first day of the month of the aware date as it was not provided.Initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.A 6.0mmx20mmx135cm (4f) sterling balloon catheter was advanced for dilation.However, without reaching the maximum burst pressure of the balloon, the balloon burst along the balloon shaft length.No patient complications were reported.
Additional Manufacturer Narrative
B5: describe event or problem: updated.B3: date of event: used the first day of the month of the aware date as it was not provided.E1: initial reporter address 1:(b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.A 6.0mmx20mmx135cm (4f) sterling balloon catheter was advanced for dilation.However, without reaching the maximum burst pressure of the balloon, the balloon burst along the balloon shaft length.No patient complications were reported.It was further reported that the balloon ruptured during initial inflation.The device was removed intact, and another balloon was used to complete the procedure.Furthermore, the patient condition was good post-procedure.
Additional Manufacturer Narrative
B3: date of event: used the first day of the month of the aware date as it was not provided.E1: initial reporter address 1: (b)(6).Device evaluated by mfr.: returned product consisted of a sterling balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a longitudinal tear in the balloon 14mm from the tip and is approximately 18mm long.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there is a longitudinal tear in the balloon.
Event or Problem Description
It was reported that balloon rupture occurred.A 6.0mmx20mmx135cm (4f) sterling balloon catheter was advanced for dilation.However, without reaching the maximum burst pressure of the balloon, the balloon burst along the balloon shaft length.No patient complications were reported.It was further reported that the balloon ruptured during initial inflation.The device was removed intact, and another balloon was used to complete the procedure.Furthermore, the patient condition was good post-procedure.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16570514
• Report Number: 2124215-2023-12610
• Device Sequence Number: 14683869
• Product Code: DQY
• UDI-Device Identifier: 08714729123729
• UDI-Public: 08714729123729
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/10/2023

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: 09/25/2025
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0030219243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/13/2023
• Supplement Date Received by Manufacturer: 03/21/2023; 04/05/2023
• Initial Report FDA Received Date: 03/19/2023
• Supplement Report FDA Received Date: 03/23/2023; 04/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2022
• 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