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

Model Number 24690

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Perforation of Vessels (2135)

Event Date 01/14/2021

Event Type  Death  

Event Description

It was reported that vessel perforation and bleeding occurred, and the patient died.The 100% stenosed, 8mm x 15 cm in length target lesion was located in the mildly tortuous and moderately calcified right iliac artery.An 8x60x75 and 10x80x75 epic vascular stents were advanced and implanted without issue.Post dilatation was then performed with an 8.0mmx60mmx135cm sterling balloon catheter; however, perforation was noted.The physician administered protamine to the patient.Hemostasis was then performed by dilatation for 80 minutes with the same balloon catheter and the device was able to stop the bleeding.On the following day, re-bleeding was noted, and 2 non-boston scientific stents were placed.Two days post procedure, the patient died.

• 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: 11267466
• MDR Text Key: 229896572
• Report Number: 2134265-2021-01034
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08714729757559
• UDI-Public: 08714729757559
• 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: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/13/2021
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0023082988
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2018
• 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
• Treatment: IMAGING CATHETER: CXI; INTRODUCER SHEATH: PARENT
• Patient Outcome(s): Death