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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 M00562341
Device Problems Failure to Deliver Energy (1211); Failure to Cut (2587)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/22/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that a captivator medium hexagonal stiff snare was used to remove a large pedunculated polyp with stalk during an unknown procedure performed on (b)(6) 2022.It was reported that during the procedure, the snare did not cut or cauterize the target polyp.They could hear the pedal was working but electrical energy wasn't working at all.The procedure was completed with a sensation snare.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block b3: the reported event date is january 22, 2022; the event date listed in mw5108468 is february 14, 2022.Block d4: the reported lot number is 0028420760; the lot number listed in mw5108468 is 28201832.Block g2: report source (user facility) maude report mw5108468 received on april 14, 2022.Block h6: problem code a050702 captures the reportable event of snare loop cutting problems.Problem code a090402 captures the reportable event of snare unable to deliver energy.Conclusion code d17 is being used in lieu of an adequate conclusion code for "device not returned." block h10: the device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.Block h11: block b5 and g2 has been updated based on the additional information received on april 14, 2022.
 
Event Description
It was reported to boston scientific corporation that a captivator medium hexagonal stiff snare was used to remove a large pedunculated polyp with stalk during an unknown procedure performed on (b)(6) 2022.It was reported that during the procedure, the snare did not cut or cauterize the target polyp.They could hear the pedal was working but electrical energy wasn't working at all.The procedure was completed with a sensation snare.There were no patient complications reported as a result of this event.Additional information received on april 14, 2022.Erbe unit was checked in january 2022.
 
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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 Key14031076
MDR Text Key288798047
Report Number3005099803-2022-01788
Device Sequence Number1
Product Code FDI
UDI-Device Identifier08714729019350
UDI-Public08714729019350
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 Other,User Facility
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 05/13/2022
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 NumberM00562341
Device Catalogue Number6234
Device Lot Number0028420760
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/09/2022
Initial Date FDA Received04/06/2022
Supplement Dates Manufacturer Received04/14/2022
Supplement Dates FDA Received05/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/22/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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