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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 M0063801100
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/20/2021
Event Type  Injury  
Manufacturer Narrative
(b)(6). (b)(4). The device has not been received for analysis. Upon receipt and completion of the problem 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 segura hemi basket was used in the ureter during a flexible ureteroscopy procedure performed on (b)(6) 2021. During the procedure, the distal end of the sheath detached inside the patient. The detached sheath was retrieved using a foreign body clamp. Procedure was completed with this device. There was no patient complications as a result of this event.
 
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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 Key12519087
MDR Text Key272900160
Report Number3005099803-2021-04992
Device Sequence Number1
Product Code FFL
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 Pharmacist
Type of Report Initial,Followup
Report Date 01/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM0063801100
Device Catalogue Number380-110
Device Lot Number0027089098
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/21/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/04/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/06/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/23/2021 Patient Sequence Number: 1
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