MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NEPHROMAX; CATHETER, NEPHROSTOMY

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/01/2023

Event Type  Injury  

Event Description

Boston scientific became aware of multiple events involving nephromax balloon catheters through the article "a retrospective comparison of the balloon dilator and the telescopic metal dilator for tract dilatation during percutaneous nephrolithotomy" written by chinnakhet ketsuwan, et al.According to the literature, the aim of the study was to compare the effectiveness and safety of the balloon dilator (bd) against the telescopic metal dilator (tmd).The randomized controlled study was carried out on two hundred thirty-eight patients (238) that underwent percutaneous nephrolithotomy (pcnl) between january 2011 to february 2020.They were divided into two groups based on the adopted tract dilatation technique.The balloon dilatation group included 69 cases, and the telescopic metal dilator group included 169 cases.They were analyzed in terms of demographics and perioperative outcomes.During the procedures, eight patients in the balloon dilation group and fifteen patients in the telescopic metal dilator group experienced blood loss by the postoperative decrease in hematocrit which necessitated a pack red cell (prc) transfusion.Perioperative complications were observed in 79 patients and categorized according to the modified using the clavien grading system, 46 patients had grade 1 complications, with grade 2, grade 3, and grade 4 complications in 24, five, and four patients, respectively.Postoperative insertion of a percutaneous nephrostomy drainage tube was conducted under the belief that it decreases bleeding along the tract, prevented urinary extravasation, and preserved competence of kidney drainage.Retainment of the drainage tube for 48 hours after pcnl is still a common practice in various centers, even in non-complicated procedures that did not have residual stones.However, the present study results showed no statistically significant differences with respect to operation time and the duration of hospital stay.The duration of the nephrostomy placement was longer for the balloon dilatation group at 3 days compared with the telescopic metal dilator group at 4 days.No significant differences were detected between the two dilatation methods in terms of complication rate, and no reported iatrogenic or accidental injuries to any perirenal organs.No further information has been obtained good faith efforts.

Manufacturer Narrative

Block b3: date of event was approximated to (b)(6) 2023 based on the date the manufacturer became aware of the event.Block g3: literature source: chinnakhet ketsuwan, et al."a retrospective comparison of the balloon dilator and the telescopic metal dilator for tract dilatation during percutaneous nephrolithotomy".Block d4, h4: the complainant was unable to report the suspected device upn and lot number; therefore, the manufacture date and expiration date are unknown.Block h6: imdrf patient code e0506 captures the reportable event of patient bleeding and blood loss.Imdrf impact code f08 captures the reportable event of hospitalization.Imdrf impact code f2301 captures the reportable event of additional device required.Imdrf impact code f2302 captures the reportable event of blood transfusion.Imdrf impact code f14 captures the reportable event of prolonged episode of care.

• Brand Name: NEPHROMAX
• Type of Device: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17180917
• MDR Text Key: 317636193
• Report Number: 3005099803-2023-03223
• Device Sequence Number: 1
• Product Code: LJE
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K121614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/22/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2023
• Initial Date FDA Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention