MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION POLARIS (TM) LOOP US W/O SHAFT HOLES; STENT, URETERAL

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Liver Damage/Dysfunction (1954); Pleural Effusion (2010); Renal Failure (2041); Tachycardia (2095); Ascites (2596)

Event Date 09/10/2021

Event Type  Injury  

Manufacturer Narrative

Block d4, h4: the complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Block g2: literature source journal article: iju case reports, abdominal compartment syndrome after endoscopic combined intrarenal surgery.(b)(6) 2022; doi 10.1002/iju5.12537.Block h6: imdrf patient code e1104 captures the reportable event of liver damage/dysfunction.Imdrf patient code e2302 captures the reportable event of hypotension.Imdrf patient code e130501 captures the reportable event of renal failure.Imdrf patient code e1004 captures the reportable event of ascites.Imdrf patient code e0731 captures the reportable event of pleural effusion.Imdrf patient code e060109 captures the reportable event of tachycardia.Imdrf patient code e0519 captures the reportable event of reduced blood flow.Imdrf impact code f2203 captures the reportable event of imaging required.Imdrf impact code f19 captures the reportable event of surgical intervention.Imdrf impact code f08 captures the reportable event of hospitalization.Imdrf impact code f0801 captures the reportable event of intensive care.Imdrf impact code f23 captures the reportable event of unexpected medical intervention.

Event Description

Boston scientific corporation became aware of the following event through the article "abdominal compartment syndrome after endoscopic combined intrarenal surgery" written by shuhei okada, et al.According to the literature, the patient was referred to the hospital because of 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 6- fr, 24-cm ureteral stent (boston scientific polaris loop) and a 24-fr nephrostomy tube were inserted.The operation time was 107 minutes, with an uneventful postoperative course.This report captures the event involving the polaris loop stent that was placed during the first stage surgery.The second stage surgery, under general anesthesia, occurred on (b)(6) 2021.A stone free status was achieved during the operation with an operation time of 114 minutes.The patient was placed in the modified valdivia position.The antegrade-side surgeon placed a 24-fr sheath as the percutaneous tract.The retrograde-side surgeon inserted a ureteral access sheath.Irrigation fluid was located approximately 50 centimeters above the patient.It was challenging for the antegrade-side surgeon to approach the residual stone in the inferior renal calyx due to the renal column.To avoid injury to the kidney, the nephroscope was moved as little as possible.Therefore, they fragmented the residual stone using the ureteroscope and the fragments were removed via the percutaneous tract (pass the ball technique).Intraoperative bleeding was minimal, and renal pelvic or ureteral injury was not detected.Hemodynamic parameters remained stable, and airway pressure did not increase intraoperatively.However, when the drapes were removed, the patient's abdomen was markedly distended, and cyanosis in both legs was observed.Heart rate increased to 100 beats per minute, and systolic blood pressure dropped to 70 mmhg.Diagnosis was difficult using only bedside ultrasonography; hence, a computed tomography (ct scan) was performed.Imaging revealed a large volume of intraperitoneal fluid and bilateral pleural effusion.They then performed an urgent laparotomy.Approximately 2 liters of nearly transparent fluid was drained, but no peritoneal injury was detected.It was difficult to inflate the bladder when placing a ureteral stent at the end of the second surgery.Therefore, intravesical pressure, which reflects intra-abdominal pressure, was inferred as more than 50 cmh2o or 36.8 mmhg.Thus, the case was diagnosed as abdominal compartment syndrome (acs).Postoperatively, the patient required intensive care for shocked liver and acute kidney injury.She was extubated after 9 days.The nephrostomy tube and the ureteral stent were removed on the 26th and 39th postoperative days, respectively.She was discharged on the 43rd day after the second-stage operation.

• Brand Name: POLARIS (TM) LOOP US W/O SHAFT HOLES
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17171189
• MDR Text Key: 317637664
• Report Number: 3005099803-2023-03248
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 06/21/2023

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: 06/21/2023
• 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; Hospitalization
• Patient Age: 56 YR
• Patient Sex: Female