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

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

Patient Problems Unspecified Infection (1930); Sepsis (2067); Urinary Tract Infection (2120); Unspecified Kidney or Urinary Problem (4503)

Event Date 01/01/2014

Event Type  Injury  

Event Description

Boston scientific corporation became aware of the event through the article "unveiling the challenges in tandem ureteral stent management for malignant ureteral obstruction: failure rate, risk factors, and durability of their replacement", orel carmona, asaf shvero, dorit e.Zilberman, zohar a.Dotan, and nir kleinmann.Per the article, 186 patients being treated for malignant ureteral obstruction (muo) received 240 tandem ureteral stent (tus) placements.The patients underwent stenting between 2014 and 2022, then replacement procedures after 12 months.Follow up visits were performed 1 month after stenting then every 2 months thereafter.During the procedures, 2 stents would be placed simultaneously over guidewire under fluoroscopy.The procedures were performed under general anesthesia in the dorsal lithotomy position.In 67 patients, drainage of the stent failed.It was noted that 18 patients experienced sepsis, 3 patients suffered from culture-proven recurrent urinary tract infections leading to recurrent hospitalizations, 33 patients experienced a new finding of hydronephrosis, and 8 patients with acute kidney injury.

Manufacturer Narrative

Block b3: approximated based on the year the first procedures were performed.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: initial reporter facility name: (b)(6) hospital.Block g2 (literature source): journal article: orel carmona, et al, 'unveiling the challenges in tandem ureteral stent management for malignant ureteral obstruction: failure rate, risk factors, and durability of their replacement'.J.Clin.Med 2023, 12, 5251.Block h6: imdrf patient codes capture the following reportable events: e0306: sepsis.E1311: unspecified kidney or urinary problem (acute kidney injury).E1906: infection (hydronephrosis).E1310: urinary tract infection.

• Brand Name: PERCUFLEX URETERAL STENT
• 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: 18735892
• MDR Text Key: 335716008
• Report Number: 2124215-2024-08932
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: IS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/19/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention