• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Known Impact Or Consequence To Patient (2692)
Event Date 11/01/2019
Event Type  malfunction  
Manufacturer Narrative
Exact patient age unknown, but reported to be over 18 years of age. The event date reported is (b)(6) 2019; however, the procedure date reported is (b)(6) 2019. It is unknown what is the correct event/procedure date. The provided event date was chosen as a best estimate based on the report that the event occurred in (b)(6) 2019. The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown. The initial reporter address is (b)(6). (b)(4). Visual analysis of the returned device found the distal section of the sheath (tip area of the sheath) was torn/split, this condition leaves the basket exposed. Additionally, the basket wires was found kinked. Based on all available information, it is most likely that procedural or anatomical factors encountered during the procedure could have affected the device's performance and integrity. Handling and manipulation of the device during procedure could have kinked the basket wires. Also, interaction with the scope and additional devices could have torn the distal section of the sheath. Manufacturing processes includes extensive inspections to ensure that all finished devices meet specifications; however, there is no control how the devices are handle or manipulated in the field. Therefore, the most probable root cause is adverse event related to procedure since the adverse event occurred during the procedure and the device has no influence on the event. A manufacturing batch record review was unable to be performed as the lot number is unknown. However, a ship history review was performed to identify the most probable lots, and a device history record (dhr) review on the most probable lots did not identify any deviations within manufacturing/service processes that could have contributed to the event.
 
Event Description
It was reported to boston scientific corporation that a segura hemisphere basket was used in a ureteroscopy (urs) procedure. The exact date of the procedure is unknown but was reported to be either (b)(6) 2019 or (b)(6) 2019. Preliminary investigation of the device found that the sheath was torn at the distal end. 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key9582843
MDR Text Key189905190
Report Number3005099803-2019-06480
Device Sequence Number1
Product Code FFL
UDI-Device Identifier08714729341949
UDI-Public08714729341949
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 company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 01/13/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM0063801120
Device Catalogue Number380-112
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/29/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/17/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-