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

Model Number	24700
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture, shaft break and removal difficulties occurred.The patient presented with peripheral artery disease (pad) and angiogram was performed to fix a heavily calcified chronic total occlusion (cto) in external iliac to superficial femoral artery the 100% stenosed target lesion was moderately tortuous and severely calcified.A 5.0mmx60mmx135cm (4f) sterling balloon catheter was advanced for dilation.However, during initial inflation at 14 atmospheres for 10 seconds, the balloon burst.The balloon was then attempted to be removed but it was difficult; hence, the physician pulled the device with force and the balloon snapped in half.Since the balloon had burst; double negative pressure was applied to deflate and pulled the balloon in as close as possible to the shaft.Together with the wire, the balloon was fractured when removed successfully and no device fragments left inside the patient.A new sterling balloon catheter was used, and the procedure was completed.No patient complications were reported.

• 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: 17698100
• Report Number: 2124215-2023-48513
• Device Sequence Number: 6631883
• Product Code: DQY
• UDI-Device Identifier: 08714729122937
• UDI-Public: 08714729122937
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K053116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/07/2023

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: 03/26/2026
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0031313813
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2023
• Initial Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2023
• 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