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 Fever (1858); Pain (1994); Urinary Tract Infection (2120)

Event Date 09/01/2021

Event Type  Injury  

Manufacturer Narrative

Block b3: approximated based on the month and 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) university.Block g2: (literature source): journal article: yuanjiong qi, et al."a randomized controlled study of ureteral stent extraction string on patient's quality of life and stent related complications after percutaneous nephrolithotomy in the prone position".Urolithiasis (2023) 51:79.Block h6: imdrf device patient codes capture the following reportable events: e230101: fever.E2330: pain.E1310: urinary tract infection.Imdrf impact code f2303 captures the reportable event of medication required.

Event Description

Boston scientific corporation became aware of the following event through the article "a randomized controlled study of ureteral stent extraction string on patient's quality of life and stent related complications after percutaneous nephrolithotomy in the prone position".Yuanjiong qi hailong kong, haonan xing/zhihong zhangg, yue chen, shiyong qi.Per the article, the tianjin institute of urology (tjiu) technique to place and remove the ureteral stent with extraction string after percutaneous nephrolithotomy (pcnl).Additionally, we aim to compare the pain experienced during stent removal, quality of life during stent retention, and stent-related complications between patients with and without extraction string, 65 patients were included in the final analysis in the string group constructed by the tjiu technique and 66 patients in the conventional double-j ureteral stent (non-string) group.All patients underwent the surgery in a prone position under general anesthesia.They completed the ureteral stent symptom questionnaire (ussq) on postoperative days (pod) 7, as well as before their ureteral stent was removed.The visual analogue scale (vas) pain score (0 to 10) was completed immediately after the removal of the ureteral stent.Moreover, a specialized person was responsible for recording stent-related complications.All patients completed the ussq on pod 7, and we did not find a difference in scores in each field.However, there was a significant difference in the sex domain before removing the ureteral stent (4.34 vs 3.23; p = 0.01).Notably, the use of extraction string after pcnl could decrease the pain associated with stent removal significantly (mean vas scores 1.45 vs 2.76; p < 0.01).Extraction string did not increase the incidence of stent-related complications such as febrile uti (more than 38degree celius), emergency room (er) visits, acci-dental stent dislodgement, and delayed removal.Urological ultrasound or ct was used to assess the presence of residal stones (> 4 mm) one month after surgery.The complications associated with stent in both groups.In the string group, one female patient (1.5%) accidentally removed the ureteral stent after urination.Another female patient developed a febrile uti (38degree celius) and improved after taking antibiotics.Two male patients (3%) called the doctor to consult whether they could take oral medication for pain relief.In the non-string group, one patient presented to the emergency department with a febrile uti (38degree celius).The retention time of the stent had to be extended for two patients in the non-string group due to the lack of sufficient sterilized cystoscopes.However, the ureteral stent in the string group was removed either by a physician in the hospital outpatient clinic or by themselves under the guidance of a physician.In summary, there was no statistically significant difference in stent-related complications between the two groups (p > 0.05).The ureteral stent was removed from all patients within 2 to 4 weeks postoperatively.For the string group, the ureteral stent was removed by pulling the extraction string out directly.The ureteral stent in the non-string group was removed using rigid cystoscopic procedures in lithotomy position, with oxybuprocaine hydrochloride gel being applied to the urethra.In conclusion, placing a ureteral stent with extraction string following tjiu technique after pcnl in prone position could reduce the pain associated with ureteral stent removal, and avoid complications such as urethral injury caused by cystoscopic ureteral stent removal, while not increasing complications related to accidental removal and febrile uti.Therefore, a ureteral stent with extraction string is feasible for pcnl patients, whereas it should be chosen cautiously for sexually active patients.

• 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; 780 brookside drive; spencer 47460
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18708334
• MDR Text Key: 335404845
• Report Number: 2124215-2024-08593
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 02/14/2024

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: 01/25/2024
• Initial Date FDA Received: 02/14/2024
• 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): Required Intervention