MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPRESS SD RENAL/BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number 20188

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/26/2018

Event Type  Injury  

Event Description

It was reported via facility medwatch (b)(4) that the stent was deployed prematurely.The target lesion was located in the right superficial femoral artery (sfa).The planned procedure was a right sfa angioplasty with a non-bsc balloon and then stent the right sfa.During the right leg angiography procedure, the 6mmx18mmx150cm express sd stent was delivered to the lesion.However, the stent prematurely deployed and became disconnected.To retrieved the stent, the patient was transferred from the interventional radiology suite to the operating room for a right femoral cut down to retrieve the stent.The surgery consisted of a right popliteal exploration with the removal of the stent, a right leg thrombectomy via the popliteal artery and a right popliteal angioplasty with an unspecified bovine pericardial patch.No further patient complications were reported.

• Brand Name: EXPRESS SD RENAL/BILIARY
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8085512
• MDR Text Key: 127604674
• Report Number: 2134265-2018-62991
• Device Sequence Number: 1
• Product Code: NIN
• UDI-Device Identifier: 08714729484844
• UDI-Public: 08714729484844
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/08/2021
• Device Model Number: 20188
• Device Catalogue Number: 20188
• Device Lot Number: 0021842142
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2018
• 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: 5X4 ADMIRAL BALLOON
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR