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	05/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified both sides of the common iliac artery to external iliac artery.After inserting an unknown wire and advancing an unknown intravascular ultrasound (ivus) catheter to confirm passage of the wire, the ivus catheter did not pass through the lesion.Thus, a 2mm x 20mm x 143cm coyote es balloon catheter was advanced for dilation.However, the balloon ruptured when inflated at 10 atmospheres.Because of this, another coyote balloon catheter was used but ivus could not be advanced again due to the calcification.Therefore, it was decided to use a 3.0mmx20mmx135cm (4f) sterling balloon catheter to dilate the lesion, however, the balloon ruptured upon the third inflation at 14 atmospheres.Another sterling balloon catheter was then used, and dilation was successfully completed.An unknown guidewire was then able to pass through and the procedure was completed with the placement of an epic stent.There were no complications, and the patient returned to the ward as scheduled.

• 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: 19372946
• Report Number: 2124215-2024-31265
• Device Sequence Number: 18026934
• Product Code: DQY
• UDI-Device Identifier: 08714729755586
• UDI-Public: 08714729755586
• 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
• Report Date (Section B): 05/22/2024

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: 08/17/2026
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0032241554
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2023
• 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
• Patient Sex: Unknown