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

Model Number M0061453520

Device Problems Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)

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

Event Date 11/22/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a040601 captures the reportable investigation results of stent buckled, inside the patient.Block h10: the returned percuflex ureteral stent was analyzed, and a visual and microscopic evaluation noted that the bladder coil and the shaft was buckled.Additionally, the suture was not return.During functional inspection, a mandrel 0.036 was loaded into the device and no resistance was felt.No other problems with the device were noted.The reported event of difficult to advance was confirmed.Taking all available information into consideration, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.It is possible to conclude that this problem could be caused by operational factors, such as interaction of the device between the positioner and the guide wire.It's possible to conclude that due to the buckles found in the device coil and shaft, this could have been generated because the physician could have difficulties in order to place the device in the target, leading the physician to use an excess of force in the placement of the device leading the device to be buckled.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.

Event Description

Note: this report is one of two complaints that pertain to the same event (mfr report # 2124215-2024-05648 and mfr.Report # 2124215-2024-05950).It was reported to boston scientific corporation that a percuflex ureteral stent was used during a percutaneous nephrolithotripsy procedure in the kidney and ureters performed on (b)(6) 2022.During the procedure, it was noted that the stent could not be advanced.The procedure was successfully completed with another percuflex 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.Investigation results revealed that the stent was buckled, therefore this event has been deemed an mdr reportable event.Please see block h10 for full investigation details.

• Brand Name: PERCUFLEX
• 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: 18656087
• MDR Text Key: 334836547
• Report Number: 2124215-2024-05648
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K834468
• 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
• Report Date: 02/06/2024

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: M0061453520
• Device Catalogue Number: 145-352
• Device Lot Number: 0029816134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2023
• Initial Date FDA Received: 02/06/2024
• Date Device Manufactured: 07/27/2022
• 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