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

Model Number M0061752630

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

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

Event Date 03/18/2024

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a0401 captures the reportable event of stent shaft broken.

Event 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.

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 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
• 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: 19149316
• MDR Text Key: 341465783
• Report Number: 2124215-2024-22585
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729041184
• UDI-Public: 08714729041184
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: M0061752630
• Device Catalogue Number: 175-263
• Device Lot Number: 0030070550
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Supplement Dates Manufacturer Received: 04/23/2024
• Supplement Dates FDA Received: 05/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2022
• 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: 79 YR
• Patient Sex: Female