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

Model Number 20188

Device Problems Device-Device Incompatibility (2919); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/06/2020

Event Type  Injury  

Event Description

It was reported that stent dislodgement occurred.The target lesion was located in the superior mesenteric artery.A 6.0mmx18mmx90cm express sd stent was deployed far into the aorta.Subsequently, another 6.0mmx18mmx90cm express sd stent was advanced to anchor with the already deployed stent.However, the stent came off the balloon as well as knocking the already deployed stent out of place.Both stents were snared and retrieved from the patient.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.

• 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: 9799723
• MDR Text Key: 182388788
• Report Number: 2134265-2020-02635
• Device Sequence Number: 1
• Product Code: NIN
• UDI-Device Identifier: 08714729484851
• UDI-Public: 08714729484851
• 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: Other
• Type of Report: Initial
• Report Date: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/13/2022
• Device Model Number: 20188
• Device Catalogue Number: 20188
• Device Lot Number: 0024263570
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2019
• 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