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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 Unsealed Device Packaging (1444); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event was approximated to be (b)(6) 2019 as no event date was reported.(b)(6).(b)(4).The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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-10mm round stiff snare was opened for use during a procedure performed on an unknown date.According to the complainant, during preparation and outside the patient, when the tip of the device was checked after unpacking, it was noted that a stringlike object was found to be attached.Reportedly, the inner seal package was compromised and the stringlike object was also noted inside the sterile pouch.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block b3 (date of event): date of event was approximated to be (b)(6) 2019 as no event date was reported.Block e1: (b)(6).Block h6: problem code 2944 captures the reportable event of foreign material present in device.Problem code 1444 captures the reportable event of seal compromised.Block h10: visual analysis of the returned device revealed that the device was received out of the pouch and the pouch does not have any visible damage.The device was carefully inspected and a plastic fiber was found on the loop at the very tip.Based on the information available and the analysis performed, the most probable root cause classification is manufacturing deficiency.An investigation was opened to address the encountered failure of foreign matter present in device.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
 
Event Description
It was reported to boston scientific corporation that a captivator ii-10mm round stiff snare was opened for use during a procedure performed on an unknown date.According to the complainant, during preparation and outside the patient, when the tip of the device was checked after unpacking, it was noted that a stringlike object was found to be attached.Reportedly, the inner seal package was compromised and the stringlike object was also noted inside the sterile pouch.The procedure was completed with another captivator snare.There were no patient complications reported as a result of 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
MDR Report Key8336714
MDR Text Key136138059
Report Number3005099803-2019-00583
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,foreig
Type of Report Initial,Followup
Report Date 04/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/13/2021
Device Model NumberM00561221
Device Catalogue Number6122
Device Lot Number0022656454
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/06/2019
Date Manufacturer Received04/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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