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

Model Number	M006175262090
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of coil detachment of device or device component.
Event or Problem Description
It was reported that a perc plus stent was used during a semi-rigid ureteroscopy, laser lithotripcy, and double j catheter placement procedure.It was reported that the coil of the stent was found detached.
Additional Manufacturer Narrative
Correction block h6: imdrf impact code f1001 captures the reportable event of procedure cancelled.Imdrf impact code f1909 captures the reportable event of surgical procedure delayed.
Event or Problem Description
It was reported that a perc plus stent was used during a semi-rigid ureteroscopy, laser lithotripcy, and double j catheter placement procedure.It was reported that the coil of the stent was found detached.
Additional Manufacturer Narrative
Correction block h6: imdrf impact code f1001 captures the reportable event of procedure cancelled imdrf impact code f1909 captures the reportable event of surgical procedure delayed block h11 the percuflex plus ureteral stent was returned for analysis.After a visual inspection, it was found with the bladder coil detached, rips in the bladder coil and also the suture hole torn.Additionally, the positioner was returned with the suture returned cut.During magnification, it was observed that the bladder coil detached, rips in the bladder coil, and also the suture hole torn.The reported event of stent coil detachment was confirmed, additionally rips in the bladder coil and also the suture hole torn.These failures could have been cause due to an interaction of the device with the suture string such as entanglement, manipulation or excess of force applied over the device during the setting up.The impact code surgical procedure delayed and cancelled or rescheduled - post sedation or sedation unknown were caused due to the complaint events reported.Therefore, all compiled information on this investigation determines that the most probable cause is failure to follow instructions since problems traced to the user not following the manufacturer's instructions.
Event or Problem Description
It was reported that a perc plus stent was used during a semi-rigid ureteroscopy, laser lithotripcy, and double j catheter placement procedure.It was reported that the coil of the stent was found detached.

• 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: 19684531
• Report Number: 2124215-2024-40444
• Device Sequence Number: 19611964
• Product Code: FAD
• UDI-Device Identifier: 08714729421399
• UDI-Public: 08714729421399
• Combination Product (Y/N): N
• Initial Reporter Country: GT
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/02/2025

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: 07/18/2026
• Device Model Number: M006175262090
• Device Catalogue Number: 175-262-09
• Device Lot Number: 0032606690
• 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: 06/10/2024
• Supplement Date Received by Manufacturer: 09/26/2024; 12/10/2024
• Initial Report FDA Received Date: 07/05/2024
• Supplement Report FDA Received Date: 10/22/2024; 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2023
• 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