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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
Model Number 791-360
Device Problems Poor Quality Image (1408); Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/16/2021
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that a lithovue flexscope was used during a retrograde intrarenal surgery procedure performed on (b)(6) 2021. During procedure, there was a lot of bleeding in the kidney. In the physicians assessment this was most likely due to previous stenting or inserting of access sheath. Based upon the blood the image on the lithovue was only showing red and bright yellow. The physician decided to put in a stent and have the patient come back another day. The procedure was rescheduled due to this event. There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
(b)(4). The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed. If any further relevant information is identified, a supplemental will be filed.
 
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Brand NameLITHOVUE
Type of DeviceURETEROSCOPE 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 Key13156059
MDR Text Key288873998
Report Number3005099803-2021-08121
Device Sequence Number1
Product Code FGB
UDI-Device Identifier08714729874812
UDI-Public08714729874812
Combination Product (y/n)N
Reporter Country CodeSN
PMA/PMN Number
K153049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 01/04/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/04/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number791-360
Device Catalogue Number791-360
Device Lot Number0027798098
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/16/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/07/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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