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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 M0063801060
Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/15/2023
Event Type  malfunction  
Manufacturer Narrative
Imdrf device code a0401 is being used to capture the reportable event of the basket had a detached strand the exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.
 
Event Description
It was reported to boston scientific corporation that a segura basket hemi basket was used on an unknown date.It was reported that the basket had a detached strand before use.A photo provided by the customer shows that the basket wire was still attached to one end.There was no patient complication reported as a result of this event.
 
Event Description
It was reported to boston scientific corporation that a segura basket hemi basket was used on an unknown date.It was reported that the basket had a detached strand before use.A photo provided by the customer shows that the basket wire was still attached to one end.There was no patient complication reported as a result of this event.
 
Manufacturer Narrative
Block h6: imdrf device code a0401 is being used to capture the reportable event of the basket had a detached strand block b3: the exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block h10: the returned segura basket was analyzed, and a visual evaluation noted that device was returned with the basket open and the basket wire break.The customer provided a photo of the basket in an open state, but it is likely that one of the four wires broke.Functional test found the segura basket was able to open but could not completely close due to the due to the found issue.The reported event was confirmed.Based on all available information, it is probable that operational factors such as (handling / manipulation, interaction with other devices, excess force applied during use in preparation) caused this failure and, as a result, affected the device's performance.Additionally, this failure led to the device could not close completely.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly, and performance specifications at the time of release for distribution.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu)/product label.
 
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Brand Name
SEGURA HEMISPHERE
Type of Device
DISLODGER, 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 Key16662638
MDR Text Key312500569
Report Number3005099803-2023-01718
Device Sequence Number1
Product Code FFL
UDI-Device Identifier08714729341901
UDI-Public08714729341901
Combination Product (y/n)N
Reporter Country CodeFR
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/07/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM0063801060
Device Catalogue Number380-106
Device Lot Number0030365271
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/22/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/18/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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