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

Model Number	24690
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the non-calcified pulmonary artery.A 6.0mmx20mmx135cm (4f) sterling balloon catheter was advanced for dilation.During the procedure, the balloon ruptured upon initial inflation at 5 atmospheres for 30 seconds.The device was removed without any problems, and the procedure was completed with this device.No complications were reported, and the patient was in good condition after the procedure.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination showed multiple kinks along the shaft.The microscopic examination revealed a pinhole around 25mm from the tip of the balloon.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there is a pinhole in the balloon causing the rupture.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the non-calcified pulmonary artery.A 6.0mmx20mmx135cm (4f) sterling balloon catheter was advanced for dilation.During the procedure, the balloon ruptured upon initial inflation at 5 atmospheres for 30 seconds.The device was removed without any problems, and the procedure was completed with this device.No complications were reported, and the patient was in good condition after 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: 20578584
• Report Number: 2124215-2024-68250
• Device Sequence Number: 8106262
• Product Code: DQY
• UDI-Device Identifier: 08714729757252
• UDI-Public: 08714729757252
• 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): 11/26/2024

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
• Device Lot Number: 0032937416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 10/31/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER: 6F HEART RAIL.; GUIDE CATHETER: 6F HEART RAIL.; GUIDEWIRE: CHEVALIER 14.; GUIDEWIRE: CHEVALIER 14.; INTRODUCER SHEATH: 6F SHEATH.; INTRODUCER SHEATH: 6F SHEATH.
• Patient Sex: Unknown