MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NAVIGATOR HD; ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY

Catalog Number	250-225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Perforation (2001); Urinary Retention (2119); Hematuria (2558); Unspecified Tissue Injury (4559)
Date of Event	10/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: the exact date of the event is unknown.Approximated based on the month and year of the article was published.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: urology department, faculty of medicine, benha univerisity block g2: tamer, d., waleed, e., saad, i., ehab, e., & ahmed, a.E.(2024).Does preoperative silodosin administration facilitate ureteral dilatation during flexible ureterorenoscopy? a randomized clinical trial.Journal of international urology and nephrology 56:839-846.Https://doi.Org/1001007/s11255-023-03824-6.Block h6: patient code (b)(6) captures the reportable event of urinary retention.Patient code (b)(6) captures the reportable event of pain.Patient code (b)(6) captures the reportable event of unspecified tissue injury.Patient code (b)(6) captures the reportable event of hematuria.Patient code (b)(6) captures the reportable event of perforation.Impact code f2303 captures the reportable event of medication required.Impact code f12 captures the reportable event of serious injury/illness.
Event or Problem Description
Boston scientific became aware of an incident involving the navigator hd through an article titled "does preoperative silodosin administration facilitate ureteral dilatation during flexible ureterorenoscopy? a randomized clinical trial" by tamer diab, et al.The article aims to assess whether preoperative administration of silodosin can facilitate the placement of ureteral access sheath (uas) prior to flexible ureteroscopy (f-urs) and reduce the occurrence of ureteric injury in challenging cases.This prospective randomized clinical trial was carried out on 147 patients diagnosed with upper ureteric stone or stone kidney, non-stented.The patients were randomly divided into two equal groups.Group a (silodosin group) included patients in whom f-urs was done with a daily preoperative intake of 8 mg silodosin for 1 week and group b (placebo/control group) included patients in whom f-urs was done with the daily preoperative intake of placebo tablets.Furthermore, in group a, a total of 23 (33.3%) experienced ureteral wall injury following uas insertion, while in group b, this occurred in 40 patients (59.7%).The study found that there was a statistically significant difference in the grade of ureteral wall injury between the two groups (p < 0.001).In the multiple regression analysis, age, operative time, and silodosin were found to be significant risk factors for ureteral wall injury (p = 0.007, 0.041, and < 0.001, respectively).The administration of silodosin prior to retrograde intrarenal surgery (rirs) effectively prevented significant ureteral wall damage and reduced initial postoperative discomfort.It is worth noting that in the non-silodosin group, patients exhibited clot retention that interfered with endoscopic evaluation.The study also revealed that administering silodosin medication prior to the rirs procedure proved effective in preventing significant ureteral wall injury and reducing acute postoperative pain.Due to its rapid onset and high selectivity, using silodosin as a premedication may be a more favorable alternative to other alpha-blockers for ureteral access sheath placement.

• Brand Name: NAVIGATOR HD
• Common Device Name: ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY
• 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: 19542903
• Report Number: 2124215-2024-36239
• Device Sequence Number: 18036107
• Product Code: FED
• UDI-Device Identifier: 08714729837992
• UDI-Public: 08714729837992
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• PMA/510(K) Number: K140323
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/14/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 250-225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 06/14/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown