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

Model Number 175-272

Device Problems Difficult to Advance (2920); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2024

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a0406 captures the reportable event of stent kinked, inside the patient.

Event 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 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.

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
• Type of Device: 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
• MDR Text Key: 334738635
• Report Number: 2124215-2024-04503
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729056836
• UDI-Public: 08714729056836
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K924608
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/06/2024
• Supplement Dates Manufacturer Received: 02/14/2024
• Supplement Dates FDA Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1