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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 Problem Failure to Cut (2587)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/14/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that a captivator ii was used during a polypectomy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the snare was inserted into the scope channel for a cold polyp resection and the snare was expanded in the body.It was reported that when the target lesion was strangulated it could not be excised.It was strangulated several times, but it could not be excised.The procedure was completed with another captivator ii.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
 
Manufacturer Narrative
Block h6: problem code 2587 captures the reportable event of failure to cut.Block h10: the returned captivator ii was analyzed, and a visual evaluation noted that the device and cautery were found in good conditions.A functional evaluation noted that the device retracted and extended without issues.A continuity test was also performed and the device passed the continuity test since the device's electrical resistance was within specification, indicating a proper connection.No other issues with the device were noted.The reported event of loop failure to cut was not confirmed since the devices cannot be functionally evaluated with respect to anatomical /procedural factors encountered during the procedure.Additionally, the device passed the continuity test upon return.The product record review confirmed that this is not a new failure type and the risk is anticipated.There was no issue of a manufacturing issue, design or user issue which could have caused the complaint.Device analysis found no issues with the device during visual, electrical and functional test.Based on the information available, the investigation was assigned the most probable cause classification of no problem detected.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
 
Event Description
It was reported to boston scientific corporation that a captivator ii was used during a polypectomy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the snare was inserted into the scope channel for a cold polyp resection and the snare was expanded in the body.It was reported that when the target lesion was strangulated it could not be excised.It was strangulated several times, but it could not be excised.The procedure was completed with another captivator ii.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
 
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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
MDR Report Key11116752
MDR Text Key225094058
Report Number3005099803-2020-06512
Device Sequence Number1
Product Code FDI
UDI-Device Identifier08714729855903
UDI-Public08714729855903
Combination Product (y/n)N
PMA/PMN Number
K133987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 01/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/25/2023
Device Model NumberM00561221
Device Catalogue Number6122
Device Lot Number0026082420
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/05/2021
Date Manufacturer Received01/13/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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