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

Model Number	24690
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.A 5.0mmx60mmx135cm (4f) fg sterling balloon catheter was advanced for dilation.However, during first inflation at 6 atmospheres for 10 seconds, the balloon ruptured.The device was removed and completed the procedure with another of same device.There were no patient complications reported.Patient was in good condition.
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).E1: initial reporter city: (b)(6).
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).E1: initial reporter city: (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 and microscopic examination revealed no damages.The balloon folds were still tightly folded and there is no fluids inside the inflation lumen.Functional testing was performed by inflating the device to rated burst pressure and it was able to hold pressure.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis could not confirm the reported rupture.
Event or Problem Description
It was reported that balloon rupture occurred.A 5.0mmx60mmx135cm (4f) fg sterling balloon catheter was advanced for dilation.However, during first inflation at 6 atmospheres for 10 seconds, the balloon ruptured.The device was removed and completed the procedure with another of same device.There were no patient complications reported.Patient was in good condition.

• 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: 17805554
• Report Number: 2124215-2023-52067
• Device Sequence Number: 6691652
• Product Code: DQY
• UDI-Device Identifier: 08714729757160
• UDI-Public: 08714729757160
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 10/20/2023

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: 06/07/2025
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0029551733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2023
• Supplement Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 09/25/2023
• Supplement Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2022
• 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