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	07/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that catheter break occurred.A percuflex nephroureteral stent was selected for use for a left antegrade ureteric stenting.During the procedure, a guidewire was inserted and placed into the urinary system.Consequently, a percuflex was advanced.However, when string was pulled, the catheter split into two.The device was fully removed, and the procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6) hospital.The stent and the suture were returned for the analysis.It is possible to observe that the suture was detached, and the stent was buckled.No other issues were identified with the device and no patient complications were reported.
Event or Problem Description
It was reported that catheter break occurred.A percuflex nephroureteral stent was selected for use for a left antegrade ureteric stenting.During the procedure, a guidewire was inserted and placed into the urinary system.Consequently, a percuflex was advanced.However, when string was pulled, the catheter split into two.The device was fully removed, and the procedure was completed with another of the same 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 CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20044181
• Report Number: 2124215-2024-50172
• Device Sequence Number: 12761985
• Product Code: FAD
• UDI-Device Identifier: 08714729114086
• UDI-Public: 08714729114086
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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,Followup
• Report Date (Section B): 10/11/2024

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 Model Number: 35095
• Device Catalogue Number: 35095
• Device Lot Number: 0034129414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2024
• 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