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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 Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/21/2022
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that a 10mm captivator ii round stiff snare was used during an endoscopic submucosal resection procedure performed on (b)(6) 2022.During the procedure, the active cord connector was disconnected and could not be connected to the snare.The procedure was completed with a similar captivator ii snare.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.
 
Manufacturer Narrative
Initial reported city: (b)(6).
 
Manufacturer Narrative
Block e1 (initial reported city) (b)(6) block h11: block b5 was updated to include additional information received on (b)(6) 2022.As there is no reportable allegation against the device itself and there was no serious injury, boston scientific no longer considers this to be a reportable event.
 
Event Description
It was reported to boston scientific corporation that a 10mm captivator ii round stiff snare was used during an endoscopic submucosal resection procedure performed on (b)(6), 2022.During the procedure, the active cord connector was disconnected and could not be connected to the snare.The procedure was completed with a similar captivator ii snare.There were no patient complications reported as a result of this event.*** additional information received on (b)(6), 2022 *** it was reported that the cautery pin is still attached to the snare but would not connect to the active cord.As there is no reportable allegation against the device itself and there was no serious injury, boston scientific no longer considers this to be a reportable 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 Key15844686
MDR Text Key304138575
Report Number3005099803-2022-06942
Device Sequence Number1
Product Code FDI
Combination Product (y/n)N
Reporter Country CodeJA
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 Physician
Type of Report Initial,Followup
Report Date 12/21/2022
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 Number0029464004
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/10/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/24/2022
Initial Date FDA Received11/22/2022
Supplement Dates Manufacturer Received11/29/2022
Supplement Dates FDA Received12/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/24/2022
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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