MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Percuflex? Plus; catheter, biliary, diagnostic

Model Number	M0061752630
Medical Device Problem Codes	Break (1069); Deformation Due to Compressive Stress (2889); Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Codes	Abdominal Pain (1685); Foreign Body In Patient (2687)
Date of Event	05/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a percuflex plus ureteral stent was implanted into the right ureter of the patient during a double j (jj) stent placement performed on, (b)(6) 2026.Post procedure, on the same date, the patient experienced abdominal pain.The following day, (b)(6) 2026, x-ray imaging revealed that the stent had broken inside the patient.On (b)(6) 2026, endoscopic surgery was performed to remove the broken stent, however, the coil could not be removed and was left unretrieved.The patient's condition was stable at the conclusion of this procedure, however, further hospital observation was required.On (b)(6) 2026, another endoscopic surgery was performed and successfully retrieved all broken fragments.There was no information if a new stent was replaced and there was no information if medication was given for pain, however, it was reported that the adverse event of pain was resolved.The patient's condition following the procedure was stable.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient's year of birth was 2001.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete udi and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: patient code e2008 captures the reportable event of unretrieved device fragment.Impact code of f23 captures the reportable event of unexpected medical intervention.Impact code of f08 captures the reportable event of prolonged hospitalization.Device code of a0501 captures the reportable event of coil detachment inside the patient.Device code a040601 captures the reportable event of stent buckled material inside the patient.Device code a0406 captures the reportable event of stent material deformation inside the patient.Device code a0401 captures the reportable event of stent shaft break.Block h11: investigation analysis.The device was not returned for analysis; therefore, a technical analysis could not be performed.However, a photo was of the percuflex plus ureteral stent was provided and showed that the stent shaft was detached in six pieces, the renal coil was detached, and parts of the stent were buckled and kinked.Review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.A risk review was completed and confirmed that the event of coil detachment of device or device component, stent buckled material, stent material deformation and stent shaft break, and, pain, abdominal and unretrieved device fragments were defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Additionally, the impact code of imaging required, unexpected medical intervention, and hospitalization or prolonged hospitalization, are subsequent event of the primary anticipated event.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of adverse event related to procedure.

• 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: 50817285
• Report Number: 2124215-2026-49894
• Device Sequence Number: 21502950
• Product Code: FAD
• UDI-Device Identifier: 08714729041184
• UDI-Public: (01)08714729041184
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K924608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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
• Operator of Device: Health Professional
• Device Model Number: M0061752630
• Device Catalogue Number: M0061752630
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 09/18/2026
• 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: Hospitalization; Required Intervention
• Patient Age: 25 YR
• Patient Sex: Female