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	10/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon burst.A 6.0mm x 30mm x 135cm sterling balloon catheter was selected for use in a carotid percutaneous transluminal angioplasty procedure.The 60% stenosed carotid vessel was not tortuous and moderately calcified.During post-dilatation of a non-boston scientific carotid stent, the balloon burst on the first inflation at 12 atmospheres (atm) after three seconds.The balloon was successfully removed from the patient.No patient complications were reported.The patient was stable.
Event or Problem Description
It was reported that the balloon burst.A 6.0mm x 30mm x 135cm sterling balloon catheter was selected for use in a carotid percutaneous transluminal angioplasty procedure.The 60% stenosed carotid vessel was not tortuous and moderately calcified.During post-dilatation of a non-boston scientific carotid stent, the balloon burst on the first inflation at 12 atmospheres (atm) after three seconds.The balloon was successfully removed from the patient.No patient complications were reported.The patient was stable.It was further reported that a new balloon was used to successfully complete the procedure.

• 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: 20626563
• Report Number: 2124215-2024-69528
• Device Sequence Number: 7353577
• Product Code: DQY
• UDI-Device Identifier: 08714729757276
• UDI-Public: 08714729757276
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2024

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 Model Number: 24690
• Device Catalogue Number: 24690
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2024
• Supplement Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 11/27/2024
• 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