MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERCUFLEX NEPHROURETERAL STENT; STENT, URETERAL

Model Number 35095

Device Problem Material Deformation (2976)

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

Event Date 11/09/2023

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation.The stent was returned with the metal cannula, the stent and one accessory for the analysis.The stent was found in good conditions.It was observed the metal cannula was bent/kinked and detached.The pouch was returned, and it was observed that the pouch information matches with the complaint information.No other issues were observed in the devices.

Event Description

Reportable based on device analysis completed on 06feb2024.It was reported that the tube was kinked.A urinary percuflex nephroureteral stent was selected for use.However, during unpacking it was noted that the tube was kink.Another catheter was opened to complete the procedure.There were no patient complications reported.However, device investigations revealed that the metal cannula was detached.

• Brand Name: PERCUFLEX NEPHROURETERAL STENT
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18797021
• MDR Text Key: 336435881
• Report Number: 2124215-2024-06957
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K924608
• 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: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 35095
• Device Catalogue Number: 35095
• Device Lot Number: 0032099306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2023
• 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