MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LITHOVUE; URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number M0067913600

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

Patient Problems Abscess (1690); Chest Pain (1776); Dyspnea (1816); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Muscle Weakness (1967); Nausea (1970); Sepsis (2067); Discomfort (2330); Malaise (2359)

Event Date 09/25/2021

Event Type  Injury  

Event Description

It was reported to to boston scientific corporation that a lithovue scope was used in the kidney during a left ureteroscopy, laser lithotripsy and stent placement procedure performed on an unknown date.The patient had a procedure done with a 6fr 24cm stent with string implanted and was removed four days after the procedure.The patient experienced mild discomfort in the right quadrant and was treated with symptomatic treatment.The patient also experienced malaise, weakness, and nausea one week after the procedure, and it got worse at home when the patient developed dyspnea and chest pain.The patient was rushed to the emergency room and got admitted.In the emergency room, results showed that the patient had hypotensive bp 92 62 and hypoxic oxygen saturation of 87 percent.Immediate labs revealed elevated leukocytosis wbc, 13700 per l, azotemia cr 1.53mg dl, and positive blood and urine cultures, both growing klebsiella pneumoniae.A computed tomography was performed in the abdomen and found a 5 cm right upper pole and a 3 cm right mid pole renal abscess with parenchymal air appearing as a hypodense area.The patient was also diagnosed with right emphysematous pyelonephritis with urosepsis.After stabilization, the patient underwent right percutaneous drain placement by interventional radiologists.Drains were placed in both the mid pole and lower pole collections.Drains were draining 20 to 30cc of serosanguinous fluids.The follow up computed tomography revealed that the right mid pole abscess had been completely resolved, with the drain still present in the upper pole and minimal residual abscess.The patient condition gradually improved with conservative treatment and was discharged after three days on oral antibiotics with percutaneous drains in place.

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number.Therefore, the manufacture date and expiration date are unknown.Literature source: sharma, n., & quarrier, s.(2022).Emphysematous pyelonephritis developing in the contralateral kidney following ureteroscopy: an unusual presentation.Urology case reports, 43, 102086-102086.Https://doi.Org/10.1016/j.Eucr.2022.102086.(b)(4).

Event Description

It was reported to to boston scientific corporation that a lithovue scope was used in the kidney during a left ureteroscopy, laser lithotripsy and stent placement procedure performed on an (b)(6) 2021.The patient had a procedure done with a 6fr 24cm stent with string implanted and was removed four days after the procedure.The patient experienced mild discomfort in the right quadrant and was treated with symptomatic treatment.The patient also experienced malaise, weakness, and nausea one week after the procedure, and it got worse at home when the patient developed dyspnea and chest pain.The patient was rushed to the emergency room and got admitted.In the emergency room, results showed that the patient had hypotensive bp 92 62 and hypoxic oxygen saturation of 87 percent.Immediate labs revealed elevated leukocytosis wbc, 13700 per l, azotemia cr 1.53mg dl, and positive blood and urine cultures, both growing klebsiella pneumoniae.A computed tomography was performed in the abdomen and found a 5 cm right upper pole and a 3 cm right mid pole renal abscess with parenchymal air appearing as a hypodense area.The patient was also diagnosed with right emphysematous pyelonephritis with urosepsis.After stabilization, the patient underwent right percutaneous drain placement by interventional radiologists.Drains were placed in both the mid pole and lower pole collections.Drains were draining 20 to 30cc of serosanguinous fluids.The follow up computed tomography revealed that the right mid pole abscess had been completely resolved, with the drain still present in the upper pole and minimal residual abscess.The patient condition gradually improved with conservative treatment and was discharged after three days on oral antibiotics with percutaneous drains in place.

Manufacturer Narrative

Block b3 and b5 have been updated based on additional information received on september 29, 2022.Block d4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the manufacture date and expiration date are unknown.Block g2: literature source: sharma, n., & quarrier, s.(2022).Emphysematous pyelonephritis developing in the contralateral kidney following ureteroscopy: an unusual presentation.Urology case reports, 43, 102086-102086.Https://doi.Org/10.1016/j.Eucr.2022.102086.Block h6 (patient codes): patient code e233001 captures the reportable event of chest pain.Patient code e0306 captures the reportable event of sepsis.Patient code e17200 captures the reportable event of abscess.Patient code e2311 captures the reportable event of discomfort.Patient code e1906 captures the reportable event of unspecified infection.Patient code e1020 captures the reportable event of nausea.Patient code e1621 captures the reportable event of muscle weakness.Patient code e2321 captures the reportable event of low blood pressure/hypotension.Patient code e020204 captures the reportable event of malaise.Patient code e0717 captures the reportable event of dyspnea.Block h6 (impact code): impact code f2303 is being used to capture the patient issue requiring medication.Impact code f08 is being used to capture the patient requiring prolonged hospitalization.

• Brand Name: LITHOVUE
• Type of Device: URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15565354
• MDR Text Key: 301381063
• Report Number: 3005099803-2022-05607
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 08714729874812
• UDI-Public: 08714729874812
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/20/2022

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
• Device Model Number: M0067913600
• Device Catalogue Number: 791-360
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2022
• Initial Date FDA Received: 10/07/2022
• Supplement Dates Manufacturer Received: 09/29/2022
• Supplement Dates FDA Received: 10/20/2022
• 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): Hospitalization; Other
• Patient Age: 73 YR
• Patient Sex: Female