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

Lot Number 30996982

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/28/2023

Event Type  Injury  

Event Description

70 y/o female patient with progressive macular hypomelanosis of acute renal failure, hypertension, pyelonephritis, kidney stones, type 2 diabetes mellitus and urosepsis.On (b)(6) 2023 pt underwent a cystoscopy, left ureteroscopy with laser lithotripsy and basket stone removal, left ureteral stent exchange, right ureteral stent removal, and a left retrograde pyelogram.While performing laser lithotripsy on left ureter/ kidney, a thin metal-like foreign body was found during the flushing process and retrieved and piece saved for inspection.Also, the disposable scope had the tip sheared off and all items saved per or leadership.Manufacturer made aware.Surgeon confirmed that the metal piece came from either the retrieval basket or the scope but did occur during the (b)(6) 2023 surgery.Imaging confirmed no foreign bodies remained in pt.

• Brand Name: LITHOVUE
• Type of Device: URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 16683955
• MDR Text Key: 312910864
• Report Number: MW5116350
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/31/2023

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
• Device Lot Number: 30996982
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/04/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 87 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White