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 Consequences Or Impact To Patient (2199)
Date of Event	03/05/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.Vascular access was obtained via contralateral approach.The 95% stenosed target lesion was located in the moderately tortuous and severely calcified right common iliac artery to external iliac artery.After a guidewire crossed the lesion, intravascular ultrasound was performed.A 8.0mmx20mmx135cm sterling balloon catheter was advanced for pre-dilatation.However, upon inflation, the balloon ruptured.The device was replaced with a 8.0 x 40, 40cm mustang balloon catheter but it also ruptured during inflation at 10 atmospheres.Subsequently, three epic stents were implanted and post-dilatation was performed with a 8x60 sterling balloon catheter.The procedure was completed and no patient complications were reported.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9847490
• Report Number: 2134265-2020-03487
• Device Sequence Number: 2421759
• Product Code: DQY
• UDI-Device Identifier: 08714729757498
• UDI-Public: 08714729757498
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141150
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/18/2020

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: 01/14/2022
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0023189011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 03/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INFLATION DEVICE: EVEREST; INTRODUCER SHEATH: DESTINATION6FR