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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SEGURA HEMISPHERE DISLODGER, STONE, BASKET, URETERAL, METAL

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BOSTON SCIENTIFIC CORPORATION SEGURA HEMISPHERE DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Model Number M0063801120
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/25/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed. If any further relevant information is identified, a supplemental mdr will be filed.
 
Event Description
It was reported to boston scientific corporation that a segura hemisphere basket was used in the ureter during a retrograde intrarenal surgery (rirs) procedure performed on (b)(6) 2022. During the procedure, the sheath was torn on the distal section. The procedure was completed with another segura hemi basket. There were no patient complications reported as a result of this event. The patient's condition following procedure is reportedly stable.
 
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Brand NameSEGURA HEMISPHERE
Type of DeviceDISLODGER, STONE, BASKET, URETERAL, METAL
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 Key13792481
MDR Text Key288189975
Report Number3005099803-2022-01424
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
EXEMPT
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 03/16/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/17/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM0063801120
Device Catalogue Number380-112
Device Lot Number0028017498
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/25/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/14/2021
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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