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

Model Number 32899

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/21/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.Visual inspection was performed and the returned device was found with the shaft middle section detached/separated.The flexible cannula distal section was returned loaded in the catheter distal section.The catheter and flexible cannula show evidence of cut at section detached.The flexible cannula was unloaded form the catheter without issues.Functional inspection was performed and a 0.038" mandrel was inserted through the catheter and no resistance was felt.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 27oct2020.It was reported that the flexible cannula became stuck and broke inside the catheter.An 8.3/26 expel nephroureteral stent system with twist-loc hub was selected for use.During the procedure, it was noted that the plastic stylet would get stuck in the drainage catheter with the wire in place.Then, it was noted that the soft plastic stiffener broke off in the drainage catheter.The physician had to remove everything from the patient and start over.The procedure was completed with a non-boston scientific product.No patient complications were reported.However, device analysis revealed that the shaft middle section was detached/separated.

• 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: 10791796
• MDR Text Key: 214763241
• Report Number: 2134265-2020-15300
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729860945
• UDI-Public: 08714729860945
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/05/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 10/08/2022
• Device Model Number: 32899
• Device Catalogue Number: 32899
• Device Lot Number: 0024570701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2020
• Initial Date FDA Received: 11/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2019
• 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