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

Model Number	32899
Medical Device Problem Codes	Difficult to Insert (1316); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2021
Type of Reportable Event	Malfunction
Event or Problem 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).
Additional 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
• Common Device Name: 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
• Report Number: 2134265-2021-15187
• Device Sequence Number: 4316323
• Product Code: FAD
• UDI-Device Identifier: 08714729860938
• UDI-Public: 08714729860938
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K141344
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/14/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/19/2024
• 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/26/2021
• Initial Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown