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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH SEGURA HEMISPHERE¿ DISLODGER, STONE, BASKET, URETERAL, METAL

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BOSTON SCIENTIFIC - MARLBOROUGH SEGURA HEMISPHERE¿ DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Model Number M0063801060
Device Problems Difficult to Remove (1528); Difficult to Open or Close (2921)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/06/2018
Event Type  malfunction  
Manufacturer Narrative
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 segura hemisphere¿ stone retrieval basket was used in the ureter during a ureteroscopy with placement of a double j probe procedure performed on (b)(6) 2018. According to the complainant, during the procedure, when the segura basket was inserted into the ureter, a piece of the basket got stuck in the ureter. A laser fiber was used to cut the basket and remove it from the patient. Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date. Should additional relevant details become available, a supplemental report will be submitted.
 
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported to boston scientific corporation that a segura hemisphere stone retrieval basket was used in the ureter during a ureteroscopy with placement of a double j probe procedure performed on (b)(6) 2018. According to the complainant, during the procedure, when the segura basket was inserted into the ureter, a piece of the basket got stuck in the ureter. A laser fiber was used to cut the basket and remove it from the patient. Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date. Should additional relevant details become available, a supplemental report will be submitted.
 
Event Description
It was reported to boston scientific corporation that a segura hemisphere stone retrieval basket was used in the ureter during a ureteroscopy with placement of a double j probe procedure performed on (b)(6) 2018. According to the complainant, during the procedure, when the segura basket was inserted into the ureter, a piece of the basket got stuck in the ureter. A laser fiber was used to cut the basket and remove it from the patient. Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date. Should additional relevant details become available, a supplemental report will be submitted. Additional information received as of april 05, 2018. Basket failed to release the stone and was stuck inside the ureter. The procedure was completed with another segura basket.
 
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Brand NameSEGURA HEMISPHERE¿
Type of DeviceDISLODGER, STONE, BASKET, URETERAL, METAL
Manufacturer (Section D)
BOSTON SCIENTIFIC - MARLBOROUGH
100 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC - SPENCER
780 brookside drive
spencer IN 47460
Manufacturer Contact
nancy cutino
100 boston scientific way
marlborough, MA 01752
5086834000
MDR Report Key7385076
MDR Text Key103943376
Report Number3005099803-2018-01042
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 company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/22/2020
Device Model NumberM0063801060
Device Catalogue Number380-106
Device Lot Number20678705
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 Received04/05/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/24/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/30/2018 Patient Sequence Number: 1
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