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

Model Number M0061752530

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematuria (2558)

Event Date 09/20/2023

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a perculex plus ureteral stent was successfully implanted during a holmium laser lithotripsy plus right d-j tube implantation procedure in the right ureter performed on (b)(6) 2023.It was noted that the stent was planned to be implanted for eight to twelve weeks after the procedure, however, during the emergent follow-up, the patient had suffered repeated gross hematuria since (b)(6) 2023.The patient was given a treatment such as anti-inflammatory hemostasis and bed rest.On (b)(6) 2023, the physician removed the stent in advance, in which the gross hematuria disappeared.There were no new stents implanted and no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Manufacturer Narrative

Block h6: imdrf patient code e1302 captures the reportable event of hematuria.Imdrf impact code f23 captures the reportable event of unexpected medical intervention.

• 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: 18242616
• MDR Text Key: 329429847
• Report Number: 2124215-2023-66381
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/30/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: M0061752530
• Device Catalogue Number: 175-253
• Device Lot Number: 0030071847
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/30/2023
• 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 Outcome(s): Required Intervention
• Patient Sex: Male