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

Model Number M006175263010

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Urinary Tract Infection (2120); Burning Sensation (2146)

Event Date 03/21/2023

Event Type  Injury  

Manufacturer Narrative

The exact date of the event is unknown.The provided event date, (b)(6) 2023, was chosen as a best estimate based on the date that the manufacturer became aware of the event, (b)(6) 2023.Imdrf patient code e1310 captures the reportable event of urinary tract infection.Imdrf impact code f23 captures he reportable event of unexpected medical intervention.

Event Description

It was reported to boston scientific corporation that a percuflex plus ureteral stent was used during a urology stent procedure in the kidney on an unspecified date.Post procedure, the patient experienced burning urination and a bladder infection.An early, unplanned stent removal procedure was performed, on (b)(6) 2023, to explant the stent.Another device of the same model was implanted and used to complete the procedure.There were no medication or treatment given to the patient for the burning urination and bladder infection.The patient's condition was reported as stable, and the event was noted to have been resolved approximately one month after stent removal.

Manufacturer Narrative

Blocks d4 (lot number and expiration date) and h4 (device manufacture date) were updated based on the batch/lot number of the returned product.Block b3: the exact date of the event is unknown.The provided event date, (b)(6) 2023, was chosen as a best estimate based on the date that the manufacturer became aware of the event, (b)(6) 2023.Block h6: imdrf patient code e1310 captures the reportable event of urinary tract infection.Imdrf impact code f23 captures he reportable event of unexpected medical intervention.Block h10: the returned percuflex plus ureteral stent was analyzed, and a visual evaluation noted that the stent and the coil were in good condition and no damage was observed on the device.There was discoloration (blackened color) noted along the stent as part of the procedure.A photo of the device was also provided and showed no damage.A functional test was performed and a use of mandrel of 0.039" was used and passed through the stent successfully with no resistance.The "infection, urinary tract" reported is a known adverse event associated with the use of the device and it is noted within the instructions for use (ifu) and is known and documented in the labeling.Therefore, the most probable cause of the reported event is known inherent risk of the device.Based on a previous study for different ureteral stents and all the gathered information, the stent discoloration is caused by reaction of sulfide in urine with bismuth bicarbonate in the stent to produce bismuth sulfide.It is a non-harmful/cosmetic and does not increase stent-associated complications during use or its functionality.Therefore, no problem detected is selected as the most probable root cause for the complaint since there were no failures encountered in the device and no known problem was reported.

Event Description

It was reported to boston scientific corporation that a percuflex plus ureteral stent was used during a urology stent procedure in the kidney on an unspecified date.Post procedure, the patient experienced burning urination and a bladder infection.An early, unplanned stent removal procedure was performed, on (b)(6) 2023, to explant the stent.Another device of the same model was implanted and used to complete the procedure.There were no medication or treatment given to the patient for the burning urination and bladder infection.The patient's condition was reported as stable, and the event was noted to have been resolved approximately one month after stent removal.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16724650
• MDR Text Key: 313143477
• Report Number: 3005099803-2023-01881
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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: 07/05/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: M006175263010
• Device Catalogue Number: 175-263-01
• Device Lot Number: 0029453171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2023
• Initial Date FDA Received: 04/12/2023
• Supplement Dates Manufacturer Received: 06/12/2023
• Supplement Dates FDA Received: 07/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2022
• 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: 43 YR
• Patient Sex: Male
• Patient Weight: 55 KG