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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 791-350
Device Problem Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/28/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
 
Event Description
It was reported to boston scientific corporation that a lithovue flexscope was used during a ureteroscopy procedure performed on (b)(6) 2021. According to the event the lithovue scope was brought down the ureter from the kidney in a deflected position. The physician tried cutting the scope to release tension however the tension was not released. A semi-rigid ureteroscope was then used to leverage the lithovue scope and the lithovue scope was safely removed from the patient. There were no patient complications reported as a result of this event.
 
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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 Key12369601
MDR Text Key268199881
Report Number3005099803-2021-04427
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 08/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number791-350
Device Catalogue Number791-350
Device Lot Number0027604172
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/02/2021
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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