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

Model Number	35095
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2023.It was reported that the hub broke.A percuflex nephroureteral stent was selected for use.During the procedure, upon pulling the string to form the loop, it was noted that the hub broke.The entire drain was pulled out to completely remove the device from the patient.The procedure was completed with an alternative method.No patient complications were reported.However, device analysis revealed that the stent and suture was detached at proximal section.
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.Visual inspection was performed.The stent was returned incomplete for analysis; moreover, it was observed a mechanical cut in the middle section of the stent, and it is possible observed the stent torn created by the excessive handling of the device with the suture.Additionally, the suture was observed detached.No other issues were observed in the devices.Under the microscope it was observed that the stent was detached at the proximal section and the suture also was detached.

• Brand Name: PERCUFLEX NEPHROURETERAL STENT
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17289795
• Report Number: 2124215-2023-34595
• Device Sequence Number: 6658352
• Product Code: FAD
• UDI-Device Identifier: 08714729114093
• UDI-Public: 08714729114093
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K924608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/10/2023

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: 02/21/2025
• Device Model Number: 35095
• Device Catalogue Number: 35095
• Device Lot Number: 0028920324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2023
• Initial Report FDA Received Date: 07/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2022
• 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