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

Model Number 20188

Device Problems Difficult to Advance (2920); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/08/2019

Event Type  Injury  

Event Description

It was reported that stent dislodgement occurred.The target lesion was located in the right renal artery.A 5.0mmx19mmx90cm express sd renal/biliary drug-eluting stent was advanced through a tight stenosis.The stent would not advance through the tight stenosis.The device was being removed, it was noted during removal that the stent came off the balloon.The dislodged stent was snared out of the patient.The procedure was completed with a different device.There were no patient complications 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 CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9371163
• MDR Text Key: 167888166
• Report Number: 2134265-2019-14427
• Device Sequence Number: 1
• Product Code: NIN
• UDI-Device Identifier: 08714729390480
• UDI-Public: 08714729390480
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/08/2022
• Device Model Number: 20188
• Device Catalogue Number: 20188
• Device Lot Number: 0023615185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2019
• 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
• Patient Outcome(s): Required Intervention