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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 M00561191
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/01/2023
Event Type  malfunction  
Manufacturer Narrative
(date of event): approximated based on the date the manufacturer became aware of the event.Imdrf device code a180104 captures the reportable event of foreign material found in device.
 
Event Description
It was reported to boston scientific corporation that a 10mm captivator ii round stiff snare was examined during a routine product check performed on an unknown date.During a routine product check, the nurse clinician found a particle in the unopened packaging.No further information has been obtained despite good faith efforts.There was no patient involvement with this event.
 
Manufacturer Narrative
Block b3 (date of event): approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a180104 captures the reportable event of foreign material found in device.Block h10: investigation results: one captivator snare was received for analysis.Visual analysis of the device noted that a foreign cardboard material was found inside the sealed pouch.No other device problems were noted.The reported event of foreign material present in the device was confirmed since it was observed that a foreign cardboard material was found inside the sealed pouch.The product record review confirmed this was not a new failure type, and the risk was anticipated.There was no evidence of a manufacturing problem, design, or user problem which could have caused the complaint.Based on the analysis of the returned device and the information available, the most probable cause is manufacturing deficiency.This supplemental report was not able to be submitted on time by boston scientific because of delayed acknowledgments from fda for the initial report.An fda system issue resulted in delayed acknowledgments.This report will not be considered late because it resulted from an fda system issue.
 
Event Description
It was reported to boston scientific corporation that a 10mm captivator ii round stiff snare was examined during a routine product check performed on an unknown date.During a routine product check, the nurse clinician found a particle in the unopened packaging.No further information has been obtained despite good faith efforts.There was no patient involvement with 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 Key16518137
MDR Text Key311042632
Report Number3005099803-2023-01244
Device Sequence Number1
Product Code FDI
UDI-Device Identifier08714729855934
UDI-Public08714729855934
Combination Product (y/n)N
Reporter Country CodeSN
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 Nurse
Type of Report Initial,Followup
Report Date 05/26/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00561191
Device Catalogue Number6119
Device Lot Number0030546165
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/09/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/15/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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