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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 Consequences Or Impact To Patient (2199)
Event Date 05/23/2019
Event Type  malfunction  
Manufacturer Narrative
The patients exact age was not reported, however the patient was reported to be over the age of 18.(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 ii-25mm round stiff snare was prepared for use in the colon during a polypectomy procedure performed on (b)(6) 2019.According to the complainant, during preparation and prior to the procedure, it was noted that there were two hairs inside the unopened sterile pouch of the device.Reportedly, the inner seal package was not compromised and there was no damage noted to the inner sterile pouch of the device.The procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
 
Event Description
It was reported to boston scientific corporation that a captivator ii-25mm round stiff snare was prepared for use in the colon during a polypectomy procedure performed on (b)(6) 2019.According to the complainant, during preparation and prior to the procedure, it was noted that there were two hairs inside the unopened sterile pouch of the device.Reportedly, the inner seal package was not compromised and there was no damage noted to the inner sterile pouch of the device.The procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
 
Manufacturer Narrative
Block a2: the patients exact age was not reported, however the patient was reported to be over the age of 18.Block h6: device problem code 2944 captures the reportable event of foreign material present in device.Block h10: investigation results visual evaluation of the returned device revealed that the device had a hair inside the sealed package.Based on the information available and the analysis performed, the most probable root cause is "manufacturing deficiency." an investigation was opened to address the failure of foreign matter inside the sealed pouch.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
 
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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 Key8687641
MDR Text Key147618497
Report Number3005099803-2019-02761
Device Sequence Number1
Product Code FDI
UDI-Device Identifier08714729855934
UDI-Public08714729855934
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,foreig
Type of Report Initial,Followup
Report Date 07/31/2019
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 Expiration Date01/31/2022
Device Model NumberM00561191
Device Catalogue Number6119
Device Lot Number0023283585
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/17/2019
Initial Date Manufacturer Received 05/23/2019
Initial Date FDA Received06/11/2019
Supplement Dates Manufacturer Received07/10/2019
Supplement Dates FDA Received07/31/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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