MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERCUFLEX URINARY DIVERSION STENT SET; CATHETER, NEPHROSTOMY

Model Number	M0061602100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Note: this report is one of two complaints that pertain to the same event (mfr.Report mfr.Report # 2124215-2023-70020).It was reported to boston scientific corporation that a percuflex urinary diversion stent set was used during a flexible ureteroscopy procedure to treat kidney stones in the urethra, bladder and ureter.The exact event date was not reported.During the procedure, when the device was inserted, the stent was found broken.The procedure was successfully completed with non-boston scientific device.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Additional Manufacturer Narrative
Block b3: date of event was approximated to november 1, 2023, based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0401 captures the reportable event of stent shaft broken.

• Brand Name: PERCUFLEX URINARY DIVERSION STENT SET
• Common Device Name: CATHETER, NEPHROSTOMY
• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18343857
• Report Number: 2124215-2023-70013
• Device Sequence Number: 5531780
• Product Code: LJE
• UDI-Device Identifier: 08714729297178
• UDI-Public: 08714729297178
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K830803
• 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): 12/18/2023

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 Model Number: M0061602100
• Device Catalogue Number: 160-210
• Device Lot Number: 0030931336
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 12/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2023
• 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