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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 M00562451
Device Problems Mechanical Problem (1384); Failure to Cut (2587)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 08/01/2020
Event Type  Injury  
Manufacturer Narrative
The exact date of the event is unknown.The provided event date of (b)(6) 2020 was chosen as a best estimate based on the date that the manufacturer became aware of the event.The complainant was unable to provide the device lot number.Therefore, the manufacture and expiration dates are unknown.(b)(4).The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that a captivator small hexagonal stiff snare was used on an unknown procedure performed on an unknown date.According to the complainant, they have been ongoing issues with the device not cutting well and the snares not exit the catheter fully.Reportedly, the patient had a post polypectomy bleed and came back to the facility.In the physician's assessment, the physician was undecided whether the snare caused or contributed to the bleeding.Although it was reported that there was intervention conducted to address the bleeding, it was not reported what intervention was provided.This event did not lead to the patient's prolonged hospitalization.
 
Event Description
It was reported to boston scientific corporation that a captivator small hexagonal stiff snare was used on an unknown procedure performed on an unknown date.According to the complainant, they have been ongoing issues with the device not cutting well and the snares not exit the catheter fully.Reportedly, the patient had a post polypectomy bleed and came back to the facility.In the physician's assessment, the physician was undecided whether the snare caused or contributed to the bleeding.Although it was reported that there was intervention conducted to address the bleeding, it was not reported what intervention was provided.This event did not lead to the patient's prolonged hospitalization.
 
Manufacturer Narrative
Block b3: the exact date of the event is unknown.The provided event date of (b)(6) 2020 was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block d4, h4: the complainant was unable to provide the device lot number.Therefore, the manufacture and expiration dates are unknown.Block h6: patient code 1888 captures the reportable event of post polypectomy bleed.Problem code 2587 captures the reportable event of snare loop failed to cut.Block h10: the device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.Block h11: block h1 has been corrected.
 
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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
MDR Report Key10479642
MDR Text Key224309067
Report Number3005099803-2020-03680
Device Sequence Number1
Product Code FDI
UDI-Device Identifier08714729071068
UDI-Public08714729071068
Combination Product (y/n)N
PMA/PMN Number
K131700
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 09/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00562451
Device Catalogue Number6245
Was Device Available for Evaluation? No
Date Manufacturer Received09/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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