Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPTIVATOR II; SNARE, FLEXIBLE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION CAPTIVATOR II; SNARE, FLEXIBLE Back to Search Results
Model Number M00561223
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/05/2021
Event Type  Injury  
Manufacturer Narrative
(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 used to remove polyps in the colon during a polypectomy procedure performed on (b)(6) 2021.It was reported that during the procedure and inside the patient, the head of the snare came off while resecting a polyp.They removed the head of the snare and the catheter.However, it was not reported how the snare loop was removed.There were no issues noted upon opening the package and no other issues noted with the device.The procedure was completed with another snare.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be fine.
 
Event Description
It was reported to boston scientific corporation that a captivator ii-10mm round stiff snare was used to remove polyps in the colon during a polypectomy procedure performed on (b)(6) 2021.It was reported that during the procedure and inside the patient, the head of the snare came off while resecting a polyp.They removed the head of the snare and the catheter.However, it was not reported how the snare loop was removed.There were no issues noted upon opening the package and no other issues noted with the device.The procedure was completed with another snare.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be fine.
 
Manufacturer Narrative
Block h6: problem code a0501 captures the reportable event of snare loop detachment with retrieval.Block h10: investigation results a captivator ii-10mm round stiff snare was received for analysis.Visual inspection of the returned device revealed that the loop and cannula were detached from the cable and they were not returned.No other issues were noted.The reported event of "loop detachment of device or device component" was confirmed since the analysis of the device found the loop and cannula were detached from the cable.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is manufacturing deficiency.An investigation to address this issue is in progress.A review of the device history record (dhr) was performed and confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CAPTIVATOR II
Type of Device
SNARE, FLEXIBLE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key11922960
MDR Text Key254306424
Report Number3005099803-2021-02528
Device Sequence Number1
Product Code FDI
UDI-Device Identifier08714729861317
UDI-Public08714729861317
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,health
Type of Report Initial,Followup
Report Date 08/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/24/2024
Device Model NumberM00561223
Device Catalogue Number50297
Device Lot Number0026840578
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/31/2021
Date Manufacturer Received07/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-