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

Model Number M0061752530

Device Problems Material Deformation (2976); Migration (4003)

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

Event Date 10/20/2023

Event Type  Injury  

Manufacturer Narrative

Block h6: imdrf device code a04060 captures the reportable event of stent kinked, inside the patient.Imdrf device code a010402 captures the reportable event of stent migration.

Event Description

It was reported to boston scientific corporation that a percuflex plus ureteral stent was used during a ureteral calculus procedure in the ureter performed on (b)(6) 2023.During the procedure, when the stent was implanted, it fell out.It was found that the stent was kinked.The procedure was successfully completed with another percuflex plus ureteral stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.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 ureteral calculus procedure in the ureter performed on (b)(6) 2023.During the procedure, when the stent was implanted, it fell out.It was found that the stent was kinked.The procedure was successfully completed with another percuflex plus ureteral stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.A photo of the complaint device was provided and showed that the stent was kinked.

Manufacturer Narrative

Block h6: imdrf device code a04060 captures the reportable event of stent kinked, inside the patient.Imdrf device code a010402 captures the reportable event of stent migration.Block h10: the returned percuflex plus ureteral stent was analyzed, and a microscope and visual evaluation noted that the shaft kinked.Additionally, the suture and positioner were not returned.The media inspection noted that the photo shows that the stent shaft was kinked.No other problems with the device were noted.The reported event of stent kinked was confirmed; however, the reported stent migration could not be tested, analyzed or replicated on the product analysis laboratory; therefore, that event is not confirmed.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.The reported migration on the complaint is a known adverse event associated with the use of the device.Regarding the reported complaint stent kinked, it may be related with some other factors such as excessive 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, 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.

• 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 ; 5086834015
• MDR Report Key: 18141678
• MDR Text Key: 328186202
• Report Number: 2124215-2023-63184
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729056812
• UDI-Public: 08714729056812
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K924608
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0061752530
• Device Catalogue Number: 175-253
• Device Lot Number: 0030325686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2023
• Initial Date FDA Received: 11/15/2023
• Supplement Dates Manufacturer Received: 12/08/2023
• Supplement Dates FDA Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 75 KG