MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERCUFLEX PLUS; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M006175263010
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device problem code a0401 captures the reportable event of stent shaft break.
Event or Problem Description
It was reported that, during a ureteroscopy procedure, a perculfex plus ureteral stent was going to be used.During preparation, the physician found that the stent was fractured.Another of the same was used to successfully complete the procedure.No patient complications were reported.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Additional Manufacturer Narrative
Block h6: device problem code a0401 captures the reportable event of stent shaft break.Block h11: the percuflex ureteral stent device was returned for analysis and underwent a thorough analysis.Visual analysis identified that the bladder coil was detached probably caused by the suture.The detached section was not returned.Based on the information available, it is possible to conclude that the problem of bladder coil was detached and one drainage hole deformed could be caused by operational factors.If the retrieval line gets entangled in the bladder coil and is removed using excess force, the stent could get detached during the preparation affecting the performance of the device.Also, there was evidence that the suture was removed since it was not returned.Probably the excess of force applied to remove the suture could have caused the detachment of the bladder coil and the deformation of the drainage hole.A conclusion code of adverse event related to procedure was assigned to this investigation.
Event or Problem Description
It was reported that, during a ureteroscopy procedure, a perculfex plus ureteral stent was going to be used.During preparation, the physician found that the stent was fractured.Another of the same was used to successfully complete the procedure.No patient complications were reported.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• Brand Name: PERCUFLEX PLUS
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• 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: 19755454
• Report Number: 2124215-2024-43517
• Device Sequence Number: 9145378
• Product Code: FAD
• UDI-Device Identifier: 08714729302032
• UDI-Public: 08714729302032
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• 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): 01/22/2025

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: 07/14/2025
• Device Model Number: M006175263010
• Device Catalogue Number: 175-263-01
• Device Lot Number: 0030115419
• 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: 06/20/2024
• Supplement Date Received by Manufacturer: 12/30/2024
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2022
• 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