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

Model Number	M006175263010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Urinary Tract Infection (2120)
Date of Event	01/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter address: (b)(6).Patient code (b)(6) is being used to capture the reportable issue of pain.Patient code (b)(6) is being used to capture the reportable issue of urinary tract infrection.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex plus ureteral stent was used during a urology stenting procedure in the ureter performed on (b)(6) 2023.After the stent implantation, it was reported that the patient experienced pain and a bladder infection.The stent remained implanted for "about" one week, but then the physician had to remove it prior to the planned removal.It was noted that there was no device malfunction, and no prescribed medicine was given to the patient.The procedure was successfully completed with another of the same device.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.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex plus ureteral stent was used during a urology stenting procedure in the ureter performed on (b)(6), 2023.After the stent implantation, it was reported that the patient experienced pain and a bladder infection.The stent remained implanted for "about" one week, but then the physician had to remove it prior to the planned removal.It was noted that there was no device malfunction, and no prescribed medicine was given to the patient.The procedure was successfully completed with another of the same device.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.
Additional Manufacturer Narrative
Block e1: initial reporter address: (b)(6).Block h6: patient code e2330 is being used to capture the reportable issue of pain.Patient code e1310 is being used to capture the reportable issue of urinary tract infection.Block h10: the returned percuflex plus ureteral stent was analyzed, and a visual evaluation noted that some residues were detected as part of the procedure and stent discoloration (blackened) was seen on both coils.Additionally, the suture and positioner were not returned.A functional test was performed and used a mandrel of 0.039" that passed through the stent without resistance.No other problems with the device were noted.The reported event of "infection" and "pain" was not confirmed.Based on the information provided pain and infection were noted and according the the instructions for use (ifu), adverse events associated with retrograde or antegrade positioned indwelling ureteral stents include but are not limited to reflux-gu (e.G.Ureteral reflux), occlusion or obstruction (e.G.Catheter, stent), migration (e.G.Dislodgement), hemorrhage, infection (e.G.Sepsis, peritonitis, urinary tract infection), perforation (e.G.Bladder, ureter, kidney, renal pelvis), extravasation, encrustation, loss of renal function, edema, urinary symptoms (e.G.Frequency, urgency, incontinence, dysuria, nocturia, hematuria), pain or discomfort, stent fragmentation, fistula, hydronephrotic, stone formation, tissue damage, erosion.The reported events are known and documented in labeling.In addition, per a previous study for different ureteral stents, stent discoloration (blackened) was caused by a reaction of sulfide in urine with bismuth bicarbonate in the stent to produce bismuth sulfide, its non-harmful or cosmetic and does not increase stent, associated complications during use or it's functionality.Therefore, the most probable cause of known inherent risk of the device was selected for this event.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16399053
• Report Number: 3005099803-2023-00659
• Device Sequence Number: 6433381
• Product Code: FAD
• UDI-Device Identifier: 08714729302032
• UDI-Public: 08714729302032
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K924608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/21/2025
• 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2023
• Supplement Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 02/17/2023
• Supplement Report FDA Received Date: 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR
• Patient Sex: Male