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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 M00561243
Device Problem Failure to Deliver Energy (1211)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/26/2024
Event Type  malfunction  
Manufacturer Narrative
Block h6: imdrf device code a090402 captures the reportable event of snare unable to deliver energy.
 
Event Description
Note: this report pertains to one of three devices used during the same procedure.Refer to manufacturer report # 3005099803-2024-00506, 3005099803-2024-00504 and 3005099803-2024-00503 for the associated device information.It was reported to boston scientific corporation that a captivator ii snare was used during a colonoscopy procedure performed on (b)(6) 2024.During the procedure, the device was not conducting electrical current.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 II
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 Key18753973
MDR Text Key336888497
Report Number3005099803-2024-00506
Device Sequence Number1
Product Code FDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133987
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
Report Date 02/21/2024
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 NumberM00561243
Device Catalogue Number50297
Device Lot Number0031163026
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/26/2024
Initial Date FDA Received02/21/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/03/2023
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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