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

Model Number M0061752530

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 03/27/2024

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a0501 captures the reportable event of coil detached, inside the patient.

Event Description

It was reported to boston scientific corporation that a percuflex plus ureteral stent was used during a cystoscopic catheter replacement procedure performed on (b)(6) 2024.During the procedure, the stent was found fractured.The procedure was successfully completed with another percuflex plus 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.A photo of the complaint device was provided and showed that the coil was detached, inside the patient.

• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19131025
• MDR Text Key: 340460815
• Report Number: 2124215-2024-22574
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729056812
• UDI-Public: 08714729056812
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 04/17/2024

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
• Device Operator: Health Professional
• Device Model Number: M0061752530
• Device Catalogue Number: 175-253
• Device Lot Number: 0030530296
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2022
• 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 Age: 36 YR
• Patient Sex: Female
• Patient Weight: 60 KG