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

Model Number M0061752530

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 03/20/2024

Event Type  malfunction  

Manufacturer Narrative

Block h6: based on the imdrf device code a0401 captures the reportable event of stent shaft break.

Event Description

It was reported to boston scientific corporation that a percuflex plus ureteral stent was used in a procedure for drainage from the kidney to the bladder under endoscopy or xray fluoroscopy, performed on (b)(6) 2024.During the procedure, the stent was found fractured upon opening the package.The procedure was completed with another percuflex plus ureteral stent.The procedure was completed and there were no reported patient complications.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Event Description

It was reported that, during a flexible ureteral calculus surgery, the stent coil was detached from the end of the stent upon opening the package.The procedure was completed with another percuflex plus ureteral stent.The procedure was completed and there were no reported patient complications.

Manufacturer Narrative

Additional information was received from the complainant on (b)(6) 2024, the problem of stent shaft break was clarified to be coil detached, outside the patient.Therefore, this is considered non reportable.

• 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: 19137515
• MDR Text Key: 340836299
• Report Number: 2124215-2024-22976
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/16/2024

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: 0030530293
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2024
• Initial Date FDA Received: 04/18/2024
• Supplement Dates Manufacturer Received: 04/24/2024
• Supplement Dates FDA Received: 05/16/2024
• 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