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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 M0063801070
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/18/2020
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 segura hemisphere basket was used in the ureter during a cystoscopy left ureteroscopy stone manipulation laser lithotripsy bladder biopsy procedure performed on (b)(6) 2020. According to the complainant, during the procedure, the physician noticed a crack and an orange sheet when he deployed the basket. The basket was removed and under direct visualization, the device was found intact. The physician went back to make sure that nothing left behind. No patient complications have been reported as a result of the event. Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
 
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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 Key9722975
MDR Text Key190373814
Report Number3005099803-2020-00498
Device Sequence Number1
Product Code FFL
UDI-Device Identifier08714729341918
UDI-Public08714729341918
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/13/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/07/2022
Device Model NumberM0063801070
Device Catalogue Number380-107
Device Lot Number0023457137
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/18/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/16/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/08/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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