• 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 CAPTIVATOR II; SNARE, FLEXIBLE

  • 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 CAPTIVATOR II; SNARE, FLEXIBLE Back to Search Results
Model Number M00561191
Device Problems Detachment of Device or Device Component (2907); Difficult to Open or Close (2921)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/24/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(4).(investigation result): one captivator snare was received for analysis.Visual analysis and microscopic evaluation of the returned device revealed that the 2 in 1 (cautery pin) was broken inside of the active cord.Functional evaluation of the returned device was impossible due the device condition.The reported event of "device difficult to actuate" was confirmed since it's probable that the broken 2 in 1 (cautery pin) induced difficulty in actuating the device.Based on the analysis of the returned device and the information available, the code selected as the most probable cause is design inadequate for purpose.There is an investigation in place to address this problem.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.
 
Event Description
It was reported to boston scientific corporation that a 25mm captivator ii round stiff snare was used during a procedure performed on (b)(6) 2022.During the procedure, the device was difficult to actuate.The procedure was completed with a different device.There were no patient complications reported as a result of this event.Note: this event has been deemed an mdr-reportable event based on investigation results which revealed that the cautery pin was detached.Please see block for full investigation details.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CAPTIVATOR II
Type of Device
SNARE, FLEXIBLE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC DE COSTA RICA S.R.L.
2546 calle primera
propark, coyol
alajuela
CS  
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key13934401
MDR Text Key288183701
Report Number3005099803-2022-01494
Device Sequence Number1
Product Code FDI
UDI-Device Identifier08714729855934
UDI-Public08714729855934
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K133987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 03/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/23/2024
Device Model NumberM00561191
Device Catalogue Number6119
Device Lot Number0027553467
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/14/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/03/2022
Initial Date FDA Received03/28/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/24/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-