MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPEL NEPHROURETERAL STENT SYSTEM WITH TWIST-LOC HUB; STENT, URETERAL

Device Problems Entrapment of Device (1212); Material Deformation (2976)

Patient Problem No Code Available (3191)

Event Date 04/01/2020

Event Type  Injury  

Manufacturer Narrative

Event date - used (b)(6) 2020 as the estimated event date based on the aware date of (b)(6) 2020 as there was no reported event date.

Event Description

It was reported that the stent was snared for retrieval.An expel nephroureteral stent system with twist-loc hub was selected for use.The deployment string attached to the end of the pigtail that resulted in the pigtail becoming un-coiled upon deployment, then getting caught in a calyx.Attempts were made to modify the location of the deployment string but this does not work well.The case took up to 45-60 minutes.Snaring was required to retrieve one of these stents.

• Brand Name: EXPEL NEPHROURETERAL STENT SYSTEM WITH TWIST-LOC HUB
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10066388
• MDR Text Key: 191290273
• Report Number: 2134265-2020-06601
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 05/18/2020

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/30/2020
• Initial Date FDA Received: 05/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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