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

Model Number	35095
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent detachment occurred.A percuflex nephroureteral stent was selected for use in the urinary bladder.During the procedure, the nephroureteral stent was advanced over the guidewire into the urinary bladder.The guidewire was removed to form the nephroureteral stent.The suture was pulled to create the pigtail and upon removing over the wire, it was noted that a fracture occurred at the proximal end of the catheter distal to the hub and at the distal third.The guide wire was readvanced to remove the nephroureteral stent and resistance was met.The nephroureteral stent was removed over the wire.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the stent was returned for analysis.Visual and microscopic inspection revealed the stent was detached at the proximal and middle sections.Both pigtail sections were kinked.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that the stent detachment occurred.A percuflex nephroureteral stent was selected for use in the urinary bladder.During the procedure, the nephroureteral stent was advanced over the guidewire into the urinary bladder.The guidewire was removed to form the nephroureteral stent.The suture was pulled to create the pigtail and upon removing over the wire, it was noted that a fracture occurred at the proximal end of the catheter distal to the hub and at the distal third.The guide wire was readvanced to remove the nephroureteral stent and resistance was met.The nephroureteral stent was removed over the wire.The procedure was completed with a different device.No patient complications were reported.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16938428
• Report Number: 2124215-2023-24219
• Device Sequence Number: 6017438
• Product Code: FAD
• UDI-Device Identifier: 08714729114086
• UDI-Public: 08714729114086
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2023

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: 10/10/2025
• Device Model Number: 35095
• Device Catalogue Number: 35095
• Device Lot Number: 0030316319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/17/2023
• Supplement Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 05/16/2023
• Supplement Report FDA Received Date: 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2022
• 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 Age: 57 YR
• Patient Sex: Female