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	05/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.Vascular access was obtained via the radial artery.The 95% stenosed target lesion was located in the mildly tortuous and moderately calcified left common femoral artery.After sheath placement, a guidewire was crossed the lesion along with a microcatheter.A 5.0mmx60mmx135cm sterling balloon catheter was advanced for dilation.However, during the second inflation at 13 atmospheres for 30 seconds, the balloon ruptured.The device was removed, and the procedure was completed with a 4mm wolverine balloon.There were no patient complications reported.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: 17091847
• Report Number: 2124215-2023-27409
• Device Sequence Number: 20376605
• Product Code: DQY
• UDI-Device Identifier: 08714729757160
• UDI-Public: 08714729757160
• 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): 06/08/2023

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: 12/14/2023
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0026512246
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2020
• 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: CRUISE, JUPITERFC3, AGOSAL; INFLATION DEVICE: NIPRO; INTRODUCER SHEATH: 6FR DESTINATION; MICRO CATHETER: PROMINENT
• Patient Sex: Unknown