• 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; 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; SNARE, FLEXIBLE Back to Search Results
Model Number M00562301
Device Problems Failure to Deliver Energy (1211); Failure to Cut (2587); Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/01/2022
Event Type  malfunction  
Event Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2022-05554 and for the associated device information.It was reported to boston scientific corporation that a captivator small oval stiff snare was prepared for use during a colonoscopy procedure performed on an unknown date.During preparation, the beamer cord was very difficult to hook into the connector.They were able to get the cord connected but it required a lot of pressure and twisting to get it attached.It was reported that the tech thought the cord was connected but it was not and they ended up cold snaring.The procedure was completed with a non-bsc product.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Event date: approximated based on the date the manufacturer became aware of the event.(b)(4).
 
Event Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2022-05554 and 3005099803-2022-05555 for the associated device information.It was reported to boston scientific corporation that a captivator small oval stiff snare was prepared for use during a colonoscopy procedure performed on an unknown date.During preparation, the beamer cord was very difficult to hook into the connector.They were able to get the cord connected but it required a lot of pressure and twisting to get it attached.It was reported that the tech thought the cord was connected but it was not and they ended up cold snaring.The procedure was completed with a non-bsc product.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: problem code a090402 captures the reportable event of snare unable to deliver energy.Problem code a050702 captures the reportable event of snare loop cutting problems.Block h10: investigation results a captivator medium hexagonal stiff snare was received for analysis.Visual inspection of the returned device revealed no problems were found.Microscope inspection noted some marks of friction on the 2 in1 connector, probably by the interaction with the active cord.Functional testing was performed, and the loop could extend and retract well.The device was tested with a boston scientific active cord and the device connected well.Additionally, the device was plugged in with a non-bsc active cord, however, the device connected well.Finally, the device was plugged in with another non-bsc active cord and the device connected well.During dimensional testing it was noted that the internal gap dimension of the 2 in 1 connector was not according to the referenced drawing.Electrical testing was performed, and the device was found within specification.No other problems were noted.The reported complaint of device failure to deliver energy was unable to be confirmed since the device passed electrical testing upon return.In addition, the 2 in 1 connector had some marks of friction probably by the same force applied to attach the handle to the active cord.The reported complaint of loop failure to cut was not confirmed since the device cannot be functionally evaluated with respect to anatomical/procedural factors encountered during the procedure.The reported event of device interaction with another device was confirmed.During dimensional analysis it was noted that some measurements of the 2 in 1 connector were not as expected.An investigation to address this problem is in progress.Based on the analysis of the returned device and the information available, the most probable cause is manufacturing deficiency.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CAPTIVATOR
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 Key15536601
MDR Text Key306323402
Report Number3005099803-2022-05555
Device Sequence Number1
Product Code FDI
UDI-Device Identifier08714729019312
UDI-Public08714729019312
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131700
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 11/10/2022
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 Model NumberM00562301
Device Catalogue Number6230
Device Lot Number0029801649
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/07/2022
Initial Date FDA Received10/04/2022
Supplement Dates Manufacturer Received10/17/2022
Supplement Dates FDA Received11/10/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/20/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-