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

Model Number	M001245500
Medical Device Problem Codes	Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that device separation occurred.A percuflex? device was selected for use during a nephrostomy insertion and/or ureteric stent insertion procedure.During the procedure, when the stent was inserted over the wire, it was difficult to advance.The thread was pulled in an attempt to reposition the stent towards the insertion site; however, the string snapped off the stent (which remained intact), and the stent became deployed in a less-than-ideal position.Given the stricture, the physician felt that the stent should not migrate.The patient would return for a second procedure to assess the stent.
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.Device evaluated by mfr: the device was returned for analysis.One ureteral stent suture was returned for analysis.Only returned the suture with the key in good conditions.However, since the catheter did not return, a proper evaluation of the complete device could not be conducted.
Event or Problem Description
It was reported that device separation occurred.A percuflex device was selected for use during a nephrostomy insertion and/or ureteric stent insertion procedure.During the procedure, when the stent was inserted over the wire, it was difficult to advance.The thread was pulled in an attempt to reposition the stent towards the insertion site; however, the string snapped off the stent (which remained intact), and the stent became deployed in a less-than-ideal position.Given the stricture, the physician felt that the stent should not migrate.The patient would return for a second procedure to assess the stent.
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.Device evaluated by mfr: the device was returned for analysis.One ureteral stent suture was returned for analysis.Only returned the suture with the key in good conditions.However, since the catheter did not return, a proper evaluation of the complete device could not be conducted.
Event or Problem Description
It was reported that device separation occurred.A percuflex? device was selected for use during a nephrostomy insertion and/or ureteric stent insertion procedure.During the procedure, when the stent was inserted over the wire, it was difficult to advance.The thread was pulled in an attempt to reposition the stent towards the insertion site; however, the string snapped off the stent (which remained intact), and the stent became deployed in a less-than-ideal position.Given the stricture, the physician felt that the stent should not migrate.The patient would return for a second procedure to assess the stent.

• Brand Name: PERCUFLEX?
• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 23151490
• Report Number: 2124215-2025-67162
• Device Sequence Number: 10145908
• Product Code: FAD
• UDI-Device Identifier: 08714729178613
• UDI-Public: (01)08714729178613(17)270928(10)34951197
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K924608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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,Followup
• Report Date (Section B): 03/02/2026

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: M001245500
• Device Catalogue Number: M001245500
• Device Lot Number: 0034951197
• 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: 08/29/2025
• Supplement Date Received by Manufacturer: 12/17/2025; 02/17/2026
• Initial Report FDA Received Date: 09/25/2025
• Supplement Report FDA Received Date: 01/13/2026; 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2024
• 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