• 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 DAKOTA 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 DAKOTA DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Model Number M0063905000
Device Problems Difficult to Open or Close (2921); Material Deformation (2976); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/01/2021
Event Type  malfunction  
Manufacturer Narrative
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. (b)(4). The returned dakota basket was analyzed, and a visual inspection noted that the grasper was in a closed position when received. The sheath was found kinked/bent. The sheath was torn/split at the distal section near the tip and residues of adhesive were found. Functional inspection found the grasper was not able to open due to the torn sheath. The reported event was confirmed. Based on all available information, it is likely that handling and manipulation of the device during its use could have contributed to the encountered issues. The kinks on the sheath can cause friction between the components at the kinked areas. The force applied to the handle in order to open and close the grasper or during its actuation can lead the sheath being torn and these can cause the grasper failure in opening and closing. Therefore, the most probable root cause is adverse event related to procedure. A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing. A search of the complaint database confirmed that no similar complaints exist for the specified lot. A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
 
Event Description
It was reported to boston scientific corporation that a dakota basket was used during a procedure performed on an unknown date. During preparation, the basket failed to open. The procedure was completed with another dakota basket. There were no patient complications as a result of this event. Investigation results revealed that the sheath was torn at the distal end; therefore, this is now an mdr reportable event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDAKOTA
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 Key12077458
MDR Text Key258726525
Report Number3005099803-2021-03107
Device Sequence Number1
Product Code FFL
UDI-Device Identifier08714729937364
UDI-Public08714729937364
Combination Product (y/n)N
Reporter Country CodeJA
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 06/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM0063905000
Device Catalogue Number63057
Device Lot Number0026766435
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/01/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/07/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/07/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-