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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPTIVATOR; SNARE, FLEXIBLE

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BOSTON SCIENTIFIC CORPORATION CAPTIVATOR; SNARE, FLEXIBLE Back to Search Results
Model Number M00562451
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/22/2022
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that a captivator small hexagonal stiff snare was used in the colon during a colonoscopy procedure performed on (b)(6) 2022.After the procedure, the tech went to disconnect the snare from the cautery cord and the brass prong inside the cautery port on the snare came out.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
Block h6: problem code (b)(6)captures the reportable event of cautery pin detached.Block h10: investigation results a captivator small hexagonal stiff snare was received for analysis.Visual and microscope analysis of the returned device revealed that the 2 in 1 pin was detached from the handle.During the product analysis the handle cord was separated from the active cord insert in order to evaluate the handle cannula.The handle cannula had torque mark which was evidence of the correct process (the 2 in 1 was correctly positioned in the active cord insert).Media inspection of the photo provided by the customer revealed that the 2 in 1 was separated from the handle.No other problems were noted.The reported complaint of cautery pin detachment of device or device component was confirmed since the device was returned with the 2 in 1 pin separated from the handle.Evidence of torque mark was noted on the handle cannula which shows that the process was done in the unit and that ensures that the component was attached correctly.These types of problems can occur during device manipulation.Most likely procedural factors such as handling of the device, the technique used by the physician during removal of the active cord thereafter could have affected its performance, leading to the reported event.Finally, based in the external form provided by the manufacturing team the product builders have to confirm the 2 in 1 pin condition several times.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is adverse event related to procedure.This is defined as the adverse event occurred during the procedure and the device had no influence on event.
 
Event Description
It was reported to boston scientific corporation that a captivator small hexagonal stiff snare was used in the colon during a colonoscopy procedure performed on (b)(6)2022.After the procedure, the tech went to disconnect the snare from the cautery cord and the brass prong inside the cautery port on the snare came out.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.
 
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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 Key15438331
MDR Text Key301980555
Report Number3005099803-2022-05205
Device Sequence Number1
Product Code FDI
UDI-Device Identifier08714729071068
UDI-Public08714729071068
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 Physician
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 NumberM00562451
Device Catalogue Number6245
Device Lot Number0029390914
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/23/2022
Initial Date FDA Received09/16/2022
Supplement Dates Manufacturer Received10/17/2022
Supplement Dates FDA Received11/10/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/12/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age73 YR
Patient SexMale
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