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

Model Number	M0061752630
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent shaft broken.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex plus ureteral stent was used during a procedure performed on (b)(6) 2024.During the procedure, when the device was unpacked, 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.A photo of the complaint device was provided and showed that the stent shaft was broken.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Additional Manufacturer Narrative
Correction: additional information was received on april 23, 2024, the stent coil was detached based on the photo provided.Due to the additional information received, the event is no longer considered reportable.Blocks b5 and h6 have been updated based on additional information received on april 23, 2024.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex plus ureteral stent was used during a procedure performed on (b)(6) 2024.During the procedure, when the device was unpacked, 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.

• 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: 19149316
• Report Number: 2124215-2024-22585
• Device Sequence Number: 7406394
• Product Code: FAD
• UDI-Device Identifier: 08714729041184
• UDI-Public: 08714729041184
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2024

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: 08/31/2025
• Device Model Number: M0061752630
• Device Catalogue Number: 175-263
• Device Lot Number: 0030070550
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2022
• 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
• Patient Age: 79 YR
• Patient Sex: Female