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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION CAPTIFLEX; SNARE, FLEXIBLE Back to Search Results
Model Number M00562422
Device Problems Electrical /Electronic Property Problem (1198); Entrapment of Device (1212); Failure to Cut (2587)
Patient Problem Tissue Damage (2104)
Event Date 08/01/2020
Event Type  malfunction  
Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.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).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that a captiflex small oval flexible snare was used during a colonoscopy procedure performed on an unknown date.According to the complainant, during the procedure, they were having trouble with cold cutting.It appeared like they were pulling through the tissue rather than a clean cut.They were also having difficulty with cautery.Reportedly, there were no signs of blanching (tissue turning white).The snare securely attached to the active cord and there were no visible issues noted with the cautery pin.They tried to troubleshoot the device by reopening and closing it.The procedure was completed with another captiflex snare.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
 
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Brand Name
CAPTIFLEX
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 Key10484659
MDR Text Key209783031
Report Number3005099803-2020-03646
Device Sequence Number1
Product Code FDI
UDI-Device Identifier08714729501657
UDI-Public08714729501657
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 company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 09/02/2020
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 Date01/28/2023
Device Model NumberM00562422
Device Catalogue Number6242-40
Device Lot Number0025124992
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/11/2020
Initial Date FDA Received09/02/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/29/2020
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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