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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION LITHOVUE; URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Perforation (2001)
Event Date 02/23/2022
Event Type  Injury  
Event Description
It was reported to boston scientific corporation, through a post market clinical follow up (pmcf) of retrospective data collection, that a lithovue empower was used during a right flexible ureteroscopy procedure performed on (b)(6) 2022.The patient had perforation and was returned to the operating room for a stent placement.
 
Manufacturer Narrative
The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).
 
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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 Key15672399
MDR Text Key302399436
Report Number3005099803-2022-05992
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 10/26/2022
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/27/2022
Initial Date FDA Received10/26/2022
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 Number1
Patient Outcome(s) Required Intervention;
Patient Age82 YR
Patient SexMale
Patient RaceWhite
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