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	05/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.
Event or Problem Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous and moderately calcified common iliac artery.A 6.0mmx60mmx135cm (4f) sterling balloon catheter was advanced for dilatation.However, during first inflation at 8 atmospheres for 5 seconds, the balloon ruptured.The device was removed using normal method without issue and the procedure was completed with a different device.No complications were reported, and the patient was in good condition post procedure.
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.The device was returned for evaluation.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual and microscopic examination revealed no damages.Functional testing was performed by inflating the device to rated burst pressure and it was able to hold pressure.No other issues were identified with the device and no patient complications were reported.
Event or Problem Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous and moderately calcified common iliac artery.A 6.0mmx60mmx135cm (4f) sterling balloon catheter was advanced for dilatation.However, during first inflation at 8 atmospheres for 5 seconds, the balloon ruptured.The device was removed using normal method without issue and the procedure was completed with a different device.No complications were reported, and the patient was in good condition post 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: 19375987
• Report Number: 2124215-2024-31377
• Device Sequence Number: 15379484
• Product Code: DQY
• UDI-Device Identifier: 08714729757313
• UDI-Public: 08714729757313
• 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): 06/24/2024

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 Expiration Date: 09/01/2025
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0030073878
• 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: 05/17/2024
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: GLADIUS.; GUIDEWIRE: GLADIUS.; INFLATION DEVICE: NIPRO.; INFLATION DEVICE: NIPRO.; INTRODUCER SHEATH: DESTINATION.; INTRODUCER SHEATH: DESTINATION.; MICRO CATHETER: ARMET.; MICRO CATHETER: ARMET.; STENT: EPIC.; STENT: EPIC.
• Patient Sex: Male