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

Model Number 32899

Device Problems Difficult to Insert (1316); Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2021

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 26nov2021.It was reported that the device became stuck.An expel nephroureteral stent system with twist-loc hub was selected for use.During the procedure, it was noted that there was difficulty advancing the plastic stiffener into the stent right out of package.The stent and the stiffener were both flushed and wiped before insertion.A bentson wire was advanced in the plastic stiffener to advance it all the way down.Then, the nephroureteral stent was inserted into the patient, but when the time came to take the plastic stiffener out, it would not come out.The stent (with the stiffener stuck inside) was removed from the patient and the procedure was completed with a non-boston scientific product.No patient complications were reported.However, device analysis revealed that the shaft section was detached/separated in three sections (proximal hub section, middle section, and pigtail section).

Manufacturer Narrative

Date of event: used (b)(6) 2021 as the event date was not reported.Device evaluated by mfr: the complaint device was received for product analysis.The returned device was found with the shaft section detached/separated in three sections (proximal hub section, middle section, and pigtail section).The hub section and pigtail section were not returned with the device.The catheter shows evidence of cut at sections detached; moreover, the catheter has a flexible cannula loaded and stretched, this cannula was unloaded from the device.Additionally, the device was returned with an unknown wire that has the flexible cannula section loaded.Once the flexible cannula was unloaded from the catheter, a mandrel 0.038" was inserted and retracted without resistance.No other issues were identified during the product analysis.

• 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.; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13001472
• MDR Text Key: 282334348
• Report Number: 2134265-2021-15187
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729860938
• UDI-Public: 08714729860938
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141344
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 32899
• Device Catalogue Number: 32899
• Device Lot Number: 0027879389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2021
• 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