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

Model Number	M0061752730
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: initial reporter address: str.Liviu rebreanu nr.35 bl m15 sc.Block h6: imdrf device code: a0401 captures the reportable event of stent shaft broken.
Event or Problem Description
It was reported to boston scientific that a percuflex plus ureteral stent was opened to be used during a laser lithotripsy procedure in the ureter performed on (b)(6) 2024.Prior to procedure, when the device was unpacked, it was noted that the stent had different consistency than usual.The procedure was completed with another percuflex plus ureteral stent.There were no patient complications reported.A photo of the complaint device was provided and showed that the stent shaft was broken.
Event or Problem Description
It was reported to boston scientific that a percuflex plus ureteral stent was opened to be used during a laser lithotripsy procedure in the ureter performed on february 15, 2023.Prior to procedure, when the device was unpacked, it was noted that the stent had different consistency than usual.The procedure was completed with another percuflex plus ureteral stent.There were no patient complications reported.A photo of the complaint device was provided and showed that the stent shaft was broken.
Additional Manufacturer Narrative
Block e1: initial reporter address: (b)(6).Block h6: imdrf device code a0401 captures the reportable event of stent shaft broken.Block h11: the percuflex plus ureteral stent was not returned; however, two pictures shows that the stent was detached in many parts, the bladder coil was stretched, and each detached part of the stent has evidence of pull until the detachment, moreover, their suture and positioner are not visible.No other problems with the device were noted.The reported event was confirmed.The device meets all manufacturing specifications required and passed all the controls and inspections.No abnormalities were reported during the assembly process.While the investigation was able to verify and confirm the reported problems, due to the lack of sufficient evidence, it is not possible to definitively establish the cause of the reported issue.Therefore, the most probable cause of the reported issue cannot be determined, and the investigation findings do not lead to a clear conclusion.As a result, cause not established is selected as the most probable cause for the complaint.

• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18861848
• Report Number: 2124215-2024-12847
• Device Sequence Number: 15543754
• Product Code: FAD
• UDI-Device Identifier: 08714729041207
• UDI-Public: 08714729041207
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• PMA/510(K) Number: K924608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 10/17/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/07/2026
• Device Model Number: M0061752730
• Device Catalogue Number: 175-273
• Device Lot Number: 0032175718
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2023
• 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
• Patient Sex: Unknown