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

Model Number	24716
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.A 6.0x220x150 sterling balloon catheter was advanced for dilatation.However, during the procedure, the balloon ruptured.The device was removed and another 6.0x150x150 sterling balloon catheter was advanced but the balloon also ruptured.The device was removed from the patient and the procedure was completed successfully.No patient complications were reported.
Event or Problem Description
It was reported that balloon rupture occurred.A 6.0x220x150 sterling balloon catheter was advanced for dilatation.However, during the procedure, the balloon ruptured.The device was removed and another 6.0x150x150 sterling balloon catheter was advanced but the balloon also ruptured.The device was removed from the patient and the procedure was completed successfully.No patient complications were reported.It was further reported that severely calcified target lesion was located in the superficial femoral artery.Both sterling balloons ruptured during the initial inflation at 6 atmospheres.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12698485
• Report Number: 2134265-2021-13446
• Device Sequence Number: 14564141
• Product Code: LIT
• UDI-Device Identifier: 08714729845485
• UDI-Public: 08714729845485
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K132430
• 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,Followup
• Report Date (Section B): 11/09/2021

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: 06/23/2024
• Device Model Number: 24716
• Device Catalogue Number: 24716
• Device Lot Number: 0027550566
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2021
• Supplement Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 10/26/2021
• Supplement Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2021
• 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