MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NEPHROSTOMY SHEATHS AND DILATORS; DILATOR, CATHETER, URETERAL

Model Number	260-150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Hemorrhage/Blood Loss/Bleeding (1888); Sepsis (2067); Urinary Incontinence (4572)
Date of Event	02/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3.Exact date of event is unknown; therefore, first day of treatment month/year has been selected.De gobbi, a., lupi, a., massari, d., stellato, a., behr, a.U., costa, g., & fiorello, m.(2023).Camposampiero tubeless percutaneous nephrolithotomy (tpcnl): easy, quick, effective, safe.Urologia journal, vol.91(2) 342-345.
Event or Problem Description
It was reported to boston scientific via an article published in the urologia journal that a study was conducted to describe the technic to perform tubeless percutaneous nephrolithotomy (tpcnl) to evaluate the procedure efficacy and safety.Tpcnl procedure utilized hemostatic matrix that is floseal for the closure of the percutaneous tract, developed through experienced at the endourology specialized center, ospedale di camposampiero.Data from patients consecutively treated from february 2017 to december 2019 for kidney stone >2 cm via pcnl, who underwent floseal direct application for percutaneous tract closure, were included.Clinical and surgical data were collected in order to evaluate the success of the procedure and possible complications.Preoperative assessment declared that procedures were performed under spinal anesthesia in 69 patients (45 males mean age 58 years old).For the procedure technique, the boston scientific sensor ptfe-nitinol guidewire with hydrophilic tip, amplatz super stiff guidewire, nephromax balloon dilator, and amplatz renal sheath were utilized.For the lithotripsy procedures of the tone, the boston scientific lumenis 20w holmium laser, and a zero tip nitinol stone retrieval basket for stone removal were utilized.All patients underwent placement of boston scientific ureteral stent percuflex plus at the end of the procedure (56 mono j stents, and 13 double j stents).In all patients the procedure was completed successfully and in 88% of subjects no further treatments were necessary; a low complication rate (6.9%) was reported.Ten patients (6.9%) experienced the following post operative complications: five had fever treated successfully with antibiotic therapy; three had self-limiting bleeding; one patient had urosepsis with positive blood culture (this patient was treated with parenteral antibiotics for 2 weeks), and one patient (who showed thin renal cortex and infected lithiasis) had urinary leakage (successfully treated with ureteral stent plus bladder catheter and antibiotic therapy for 3 weeks).According to the clavien-dindo score, six patients had complication of grade 1, three patients of grade 2, one patients of grade 3.This is 7 of 8 reports.
Event or Problem Description
It was reported to boston scientific via an article published in the urologia journal that a study was conducted to describe the technic to perform tubeless percutaneous nephrolithotomy (tpcnl) to evaluate the procedure efficacy and safety.Tpcnl procedure utilized hemostatic matrix that is floseal for the closure of the percutaneous tract, developed through experienced at the endourology specialized center, ospedale di camposampiero.Data from patients consecutively treated from february 2017 to december 2019 for kidney stone >2 cm via pcnl, who underwent floseal direct application for percutaneous tract closure, were included.Clinical and surgical data were collected in order to evaluate the success of the procedure and possible complications.Preoperative assessment declared that procedures were performed under spinal anesthesia in 69 patients (45 males mean age 58 years old).For the procedure technique, the boston scientific sensor ptfe-nitinol guidewire with hydrophilic tip, amplatz super stiff guidewire, nephromax balloon dilator, and amplatz renal sheath were utilized.For the lithotripsy procedures of the tone, the boston scientific lumenis 20w holmium laser, and a zero tip nitinol stone retrieval basket for stone removal were utilized.All patients underwent placement of boston scientific ureteral stent percuflex plus at the end of the procedure (56 mono j stents, and 13 double j stents).In all patients the procedure was completed successfully and in 88% of subjects no further treatments were necessary; a low complication rate (6.9%) was reported.Ten patients (6.9%) experienced the following post operative complications: five had fever treated successfully with antibiotic therapy; three had self-limiting bleeding; one patient had urosepsis with positive blood culture (this patient was treated with parenteral antibiotics for 2 weeks), and one patient (who showed thin renal cortex and infected lithiasis) had urinary leakage (successfully treated with ureteral stent plus bladder catheter and antibiotic therapy for 3 weeks).According to the clavien-dindo score, six patients had complication of grade 1, three patients of grade 2, one patients of grade 3.This is 7 of 8 reports.
Additional Manufacturer Narrative
B3.Exact date of event is unknown; therefore, first day of treatment month/year has been selected.De gobbi, a., lupi, a., massari, d., stellato, a., behr, a.U., costa, g., & fiorello, m.(2023).Camposampiero tubeless percutaneous nephrolithotomy (tpcnl): easy, quick, effective, safe.Urologia journal, vol.91(2) 342-345.

• Brand Name: NEPHROSTOMY SHEATHS AND DILATORS
• Common Device Name: DILATOR, CATHETER, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 20035028
• Report Number: 2124215-2024-52085
• Device Sequence Number: 15087279
• Product Code: EZN
• UDI-Device Identifier: 08714729005568
• UDI-Public: 08714729005568
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K851144
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2024

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 Model Number: 260-150
• Device Catalogue Number: 260-150
• 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: 07/29/2024
• Supplement Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 09/12/2024
• 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