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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 M00562471
Device Problems Mechanical Problem (1384); Failure to Cut (2587)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/14/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported to boston scientific corporation that a captiflex extra small oval flexible snare was used during a colonoscopy procedure performed on (b)(6) 2022.During the procedure, the snare is having difficulty cutting the polyps.The procedure was completed with another device.There were no patient complications reported as a result of this event.
 
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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 COST 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 Key15761624
MDR Text Key307507454
Report Number3005099803-2022-06499
Device Sequence Number1
Product Code FDI
UDI-Device Identifier08714729019459
UDI-Public08714729019459
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
Report Date 11/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00562471
Device Catalogue Number6247
Device Lot Number0030167107
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/17/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/21/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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