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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 M00561221
Device Problems Failure to Deliver Energy (1211); Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/18/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported to boston scientific corporation that a 10mm captivator ii round stiff snare was used during a colonoscopy procedure performed on (b)(6) 2022.During the procedure, the active cord connected to the snare but no energy was generated through the snare.The same issue happened on two different lot numbers: four boxes of lot # 29942899 and 1 box with lot # 30064113.The procedure was completed with a similar captivator ii 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 Key15990515
MDR Text Key308379258
Report Number3005099803-2022-07243
Device Sequence Number1
Product Code FDI
UDI-Device Identifier08714729855903
UDI-Public08714729855903
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K133987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/15/2022
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 NumberM00561221
Device Catalogue Number6122
Device Lot Number0029942899
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/21/2022
Initial Date FDA Received12/15/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/12/2022
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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