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

Model Number 20188

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/11/2016

Event Type  malfunction  

Event Description

It was reported that the stent dislodged.The 60-70% stenosed target lesion was located in a celiac artery.A 6.0mmx14mmx150cm express sd stent was advanced for treatment using a 7fr im guide catheter and a.018 guidewire.However, during procedure, it failed to cross the lesion.The physician attempted to pull the stent back into the guide catheter, but it would not go back.It was then attempted to remove the whole system but the stent came off of the balloon.A snare was used to remove the stent.The procedure was completed with a non-bsc device.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: 8640258
• MDR Text Key: 146063809
• Report Number: 2134265-2019-05720
• Device Sequence Number: 1
• Product Code: NIN
• UDI-Device Identifier: 08714729484820
• UDI-Public: 08714729484820
• 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: 05/24/2019

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: 04/30/2019
• Device Model Number: 20188
• Device Catalogue Number: 20188
• Device Lot Number: 0019179065
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2019
• Initial Date FDA Received: 05/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2016
• 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