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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 M00562301
Device Problems Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/30/2022
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that a captivator small oval stiff snare was used during an endoscopic mucosal resection (emr) procedure performed on (b)(6) 2022.During the procedure and outside the patient, the cautery pin was detached, and the width of the pin was closed.The connection terminal was loose and could not be connected.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Device manufacture date: the complainant was unable to provide the lot number of the suspect device.Therefore, the manufacture and expiration dates are unknown.Problem code a0501 captures the reportable event of cautery pin detached.
 
Manufacturer Narrative
Block h11: blocks b5 and h6 have been updated based on additional information received on november 23, 2022.
 
Event Description
It was reported to boston scientific corporation that a captivator small oval stiff snare was used during an endoscopic mucosal resection (emr) procedure performed on (b)(6) 2022.During the procedure and outside the patient, the cautery pin was detached, and the width of the pin was closed.The connection terminal was loose and could not be connected.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.Additional information received on november 23, 2022: the cautery pin was still connected to the snare but wouldn't connect to the active cord.
 
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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 Key15670359
MDR Text Key306886741
Report Number3005099803-2022-06211
Device Sequence Number1
Product Code FDI
UDI-Device Identifier08714729019312
UDI-Public08714729019312
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K131700
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/28/2022
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 NumberM00562301
Device Catalogue Number6230
Device Lot Number0029714357
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/30/2022
Initial Date FDA Received10/25/2022
Supplement Dates Manufacturer Received11/02/2022
Supplement Dates FDA Received11/28/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/06/2022
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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