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

Model Number	175-272
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable event of stent kinked, inside the patient.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex plus ureteral stent was used during a procedure in the ureter performed on (b)(6) 2023.During the procedure, it was noted that the stent has a few ridges that make it difficult to push safely into the ureter.The procedure was completed with another percuflex plus ureteral stent.There were no patient complications reported as a result of this event.A photo of the complaint device was provided and showed that the stent was kinked.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex plus ureteral stent was used during a procedure in the ureter performed on (b)(6) 2024.During the procedure, it was noted that the stent has a few ridges that make it difficult to push safely into the ureter.The procedure was completed with another percuflex plus ureteral stent.There were no patient complications reported as a result of this event.A photo of the complaint device was provided and showed that the stent was kinked.
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable event of stent kinked, inside the patient.Block h10: the pefcuflex plus ureteral stent was not returned however, the photo attached was analyzed, and a visual evaluation noted that the bladder coil torn and kinked.No other problems with the device were noted.The reported event of stent kinked was confirmed.However, the complaint event reported of stent difficult to advance is not confirmed, since the device was not returned, and no functional test can be performed.Taking all available information into consideration, most likely, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.During the inspection, the analysis performed to the photo attached showed evidence of stent torn.It is possible to conclude that this problem could be caused by operational factors.The retrieval line may be removed before placement at the physician's discretion.If the retrieval line is removed using excess force, the stent can get torn during the procedure affecting the performance of the device.Consequently, affect the performance of the device.Based on the kinked noted in the photo, it may be related with some other factors such as handling of the device, the technique used by the physician and normal procedural difficulties encountered during the procedure that could have possibly affected the device performance and its integrity.Therefore, the as analyzed code will be adverse event related to procedure.For the reported problem difficult to advance, the kinks observed in the device could be related to this problem, however, the device was not returned therefore the functional test can't be performed in order to confirm this issue, therefore, the as analyzed code for this issue will be cause not established.Therefore, all compiled information on this investigation determines that the most probable cause is adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on event.Block b5 change: correction to event date january 11, 2024.Additional information to the following fields of the initial reporter: block e1 (initial reporter title, initial reporter first and last name, initial reporter phone, initial reporter email, and occupation).

• 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: 18655913
• Report Number: 2124215-2024-04503
• Device Sequence Number: 8240363
• Product Code: FAD
• UDI-Device Identifier: 08714729056836
• UDI-Public: 08714729056836
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2024

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 Expiration Date: 08/20/2026
• Device Model Number: 175-272
• Device Catalogue Number: 175-272
• Device Lot Number: 0032255706
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2023
• 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