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

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/03/2021

Event Type  malfunction  

Event Description

Boston scientific became aware of multiple events involving nephromax balloon catheter through the article "abdominal compartment syndrome after endoscopic combined intrarenal surgery" written by masahiro iinuma, et al.According to the literature, the patient was referred to the hospital because of an asymptomatic gross hematuria.An abdominal radiograph revealed a left staghorn calculus that involved the renal pelvis, middle, and inferior caliceal system.Left hydronephrosis was not observed.Endoscopic combined intrarenal surgery (ecirs) was performed as a two-stage procedure.A 6fr, 24-cm polaris loop ureteral stent and a 24-fr nephrostomy tube were inserted.The operation time was 107 minutes, with an uneventful postoperative course.During a percutaneous nephrolithotomy procedure performed on (b)(6), 2021, the patient was placed in the modified valdivia position.A 0.035mm guidewire was placed as a safety guidewire in the ureteral lumen.A ureteral access sheath was placed.After the middle posterior calyx was punctured under ultrasound guidance.A 0.035mm sensor guidewire was inserted through the puncture needle, received by the lithovue flexscope, and exited through the urethra.The physician dilated the percutaneous tract to 24 fr using a nephromax balloon.The antegrade-side surgeon used a 22-fr nephroscope and swiss lithoclast.The retrograde-side surgeon used a 9.5-fr lithovue flexscope and a laser as well as a slimline sis 200.Irrigation fluid was located approximately 50cm above the patient.The lithovue flexscope could no longer be deflected in the downward direction making a retrograde approach to the inferior calyx challenging for the physician.The procedure was cancelled due to this event leaving several stones which remained in the inferior renal calyx.A 6fr, 24cm polaris loop ureteral stent and a 24fr nephrostomy tube were inserted.It is unknown if the nephromax balloon contributed to the aborted procedure.

Manufacturer Narrative

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 e1: initial reporter city: (b)(6).Block g2: literature source: okada s, saito t, ichimura y and iinuma m.Abdominal compartment syndrome after endoscopic combined intrarenal surgery.Iju case rep.2023; 6: 22 to 25.Block h6: imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.

• 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: 17183280
• MDR Text Key: 317929076
• Report Number: 3005099803-2023-03228
• Device Sequence Number: 1
• Product Code: LJE
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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?: No
• Is this a Product Problem Report?: Yes
• 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 Age: 56 YR
• Patient Sex: Female