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

Model Number 20188

Device Problem Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/05/2019

Event Type  Injury  

Event Description

It was reported that the stent dislodged.The target lesion was located in a renal artery.A 7.0mmx15mmx150cm express sd stent was advanced for treatment with a 6fr guide catheter.During procedure, the stent was unable to cross the lesion and the stent came off the balloon and landed in external iliac artery.The stent was deployed to 7.5mm so it would be opposed to the vessel wall instead of trying to retrieve it.A 5mm balloon was used to pre-dilate the renal artery and another stent was successfully deployed in the target lesion with the used of a guide.No patient complications were reported and the patient was fine.

• 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: 8636959
• MDR Text Key: 145957976
• Report Number: 2134265-2019-05729
• Device Sequence Number: 1
• Product Code: NIN
• UDI-Device Identifier: 08714729390435
• UDI-Public: 08714729390435
• 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: Physician
• Type of Report: Initial
• Report Date: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2020
• Device Model Number: 20188
• Device Catalogue Number: 20188
• Device Lot Number: 0021504344
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2019
• Initial Date FDA Received: 05/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2017
• 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
• Patient Outcome(s): Other
• Patient Age: 82 YR