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

Model Number 24690

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2020

Event Type  malfunction  

Event Description

It was reported that balloon rupture occurred.Vascular access was obtained via femoral artery using a 7f non-bsc introducer sheath.The 75% stenosed target lesion was located in the severely tortuous and moderately calcified both common iliac artery (cia) and external iliac artery (eia).A non-bsc guidewire crossed the lesion in the opposite side to the right and after ivus in eia, pre-dilatation was performed using the 4x40 non-bsc balloon catheter.After the 8x100 epic stent was placed on the eia, post dilatation was performed using a 5x100 sterling balloon catheter but remaining residual stenosis was noted.The device was replaced with a 7.0mmx40mmx135cm sterling balloon catheter.However, within specified pressure, the balloon ruptured.A 6x40 sterling balloon catheter was used and completed the post dilation.After placing the 8x100 epic stent on the left side of cia, post-dilation was performed with a 9.0 x 40, 75cm mustang balloon but failed to cross the lesion.A new 8x40 mustang balloon was used to complete the procedure.There were no patient complications were reported.

• Brand Name: STERLING
• Type of Device: 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: 10583602
• MDR Text Key: 208515021
• Report Number: 2134265-2020-13258
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08714729757443
• UDI-Public: 08714729757443
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K141150
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/24/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2022
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0023260182
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/18/2020
• Initial Date FDA Received: 09/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1