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

Model Number M0061453520

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

Patient Problems Pain (1994); Hematuria (2558)

Event Date 06/08/2023

Event Type  Injury  

Manufacturer Narrative

Block e1: initial reporter facility name: (b)(6) medicine.Initial reporter address 2: (b)(6).Block h6: imdrf patient code e2330 captures the reportable event of pain.Imdrf patient code e1302 captures the reportable event of hematuria.

Event Description

It was reported that a percuflex plus ureteral stent was used to treat a left ureteral calculi accompanied by hydrops and infection, during a transurethral holmium laser lithotripsy and ureteral stent implantation procedure under lumbar anesthesia in the ureter, performed on (b)(6) 2023.During a routine follow-up on (b)(6) 2023, the patient complained of severe pain on the left lower back accompanied by hematuria.After a spasmodic pain relief, the pain was slightly relieved.It was reported that this was prone to repeatedly occur, but there was no significant remission of hematuria.The percuflex plus ureteral stent was reportedly to be removed one week after the procedure and there was no new stent implanted to the patient.

• Brand Name: PERCUFLEX
• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17304684
• MDR Text Key: 319094210
• Report Number: 3005099803-2023-03706
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729040279
• UDI-Public: 08714729040279
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K834468
• 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: 07/12/2023

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: M0061453520
• Device Catalogue Number: 145-352
• Device Lot Number: 0028374865
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/19/2023
• Initial Date FDA Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2021
• 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 Age: 59 YR
• Patient Sex: Male