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	06/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The patient presented with peripheral artery disease (pad).The 100% stenosed target lesion was located in the severely tortuous and severely calcified common and superficial femoral arteries, and the vessel below the knee.A 5.0mm x 150mm x 150cm sterling catheter was advanced for dilation.However, during the first inflation at 6 atmospheres for 5 seconds, the balloon ruptured.The device was removed and replaced with a 2mm x 20mm x 143cm coyote es balloon catheter.However, during the first inflation at 6 atmospheres for 5 seconds, the balloon also ruptured.The device was removed, 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 17149554
• Report Number: 2124215-2023-31419
• Device Sequence Number: 12205749
• Product Code: LIT
• UDI-Device Identifier: 08714729859437
• UDI-Public: 08714729859437
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/18/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/04/2024
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0027789289
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2023
• Initial Report FDA Received Date: 06/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2021
• 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