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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPTIVATOR II; SNARE, FLEXIBLE
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BOSTON SCIENTIFIC CORPORATION CAPTIVATOR II; SNARE, FLEXIBLE Back to Search Results
Model Number M00561222
Device Problem Defective Device (2588)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/01/2020
Event Type  malfunction  
Manufacturer Narrative
The exact date of the event is unknown.The provided event date of (b)(6) 2020 was chosen as a best estimate based on the date that the manufacturer became aware of the event.(b)(4).The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that a captivator ii-10mm round stiff snare was to be used in the colon during an unknown procedure performed on an unknown date.According to the complainant, during the procedure, when the physician was using coagulation, there was a brief flame where the tip of the plastic and the snare come together during cauterization of a polyp in the colon.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
 
Event Description
It was reported to boston scientific corporation that a captivator ii-10mm round stiff snare was to be used in the colon during an unknown procedure performed on an unknown date.According to the complainant, during the procedure, when the physician was using coagulation, there was a brief flame where the tip of the plastic and the snare come together during cauterization of a polyp in the colon.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
 
Manufacturer Narrative
Block b3: the exact date of the event is unknown.The provided event date of (b)(6) 2020 was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block h6: problem code 2588 captures the reportable event of brief flame on snare device.Block h10: investigation results a captivator ii-10mm round stiff snare was received for analysis.Visual inspection of the returned device revealed that the loop was bent and was slightly burnt, indicating that the electrocautery function was activated at some point.No other issues were noted.Based on the event description, the problem was noticed during procedure and inside the patient.The customer did provide photos related to the complaint and the photo showed the generator with some parameters set.Also, another photo was shown and was blurry, however, the loop was blackened at one side and some residues were visible at the distal tip.Upon analysis of the device, it was identified that the loop was bent which was not mentioned in the complaint report and which most likely occurred as a result of device manipulation while trying to be used.Additionally, it was found that the loop was slightly burnt, indicating that the electrocautery function was activated at some point.However, there was no visible damage noted with the electrical connector on the captivator handle.Per continuity test, the resistance between the cautery and the loop wire were measured and the electrical resistance was within specifications of 7.2 ohms (the resistance shall be less than 20 ohms), indicating a proper connection.Finally, functional inspection was observed and the device contracted and extended without issues.Based on the information available and the analysis performed, the most probable root cause classification is adverse event related to procedure.A risk review of the captivator - snares was completed using the polypectomy snares risk management workbook and confirmed that the event of "excessive and/or leakage current" and "damaged/defective were defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
 
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Brand Name
CAPTIVATOR II
Type of Device
SNARE, FLEXIBLE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key11059704
MDR Text Key226650896
Report Number3005099803-2020-06323
Device Sequence Number1
Product Code FDI
UDI-Device Identifier08714729861300
UDI-Public08714729861300
Combination Product (y/n)N
PMA/PMN Number
K133987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 03/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/31/2023
Device Model NumberM00561222
Device Catalogue Number50296
Device Lot Number0025793007
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/28/2021
Date Manufacturer Received02/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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