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 CAPTIFLEX; 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 CAPTIFLEX; SNARE, FLEXIBLE Back to Search Results
Model Number M00562422
Device Problem Failure to Cut (2587)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/24/2020
Event Type  malfunction  
Manufacturer Narrative
(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 captiflex small oval flexible snare was used to remove a 13 mm polyps in the colon during a colonoscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure and inside the patient, the snare would not fully cut through the 13 mm target polyp.Reportedly, the snare was securely attached to the active cord and no visible issue was noted with the cautery pin.Also, no other issues were noted with this device.The procedure was completed with another captiflex snare.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.
 
Manufacturer Narrative
Block h6: problem code 2587 captures the reportable event of snare loop failed to cut.Block h10: investigation results: a captiflex small oval flexible snare was received for analysis.Visual inspection of the returned device revealed that the device did not have any defective condition.Also, upon functional inspection, the device was tested in the 10inch loop fixture and the loop was able to extend.Additionally, the device passed the dimensional and continuity inspection.The resistance in the device measured 9.5 ohms.According to the specification, resistance should be less than 20 ohms, therefore, this measurement passed the test.No other issues were noted.Based on the event description, the problem was noticed during procedure and inside the patient.There were no issues detected in the device, the analysis to the device include: visual, dimensional, functional and continuity test and all the tests passed.Based on the information available and the analysis performed, the most probable root cause classification is no problem detected due to the device complaint or problem cannot be confirmed.A risk review of the captiflex - snares was completed and confirmed that the event of loop failure to cut was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.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 captiflex small oval flexible snare was used to remove a 13 mm polyps in the colon during a colonoscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure and inside the patient, the snare would not fully cut through the 13 mm target polyp.Reportedly, the snare was securely attached to the active cord and no visible issue was noted with the cautery pin.Also, no other issues were noted with this device.The procedure was completed with another captiflex snare.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CAPTIFLEX
Type of Device
SNARE, FLEXIBLE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key10696591
MDR Text Key211864319
Report Number3005099803-2020-04636
Device Sequence Number1
Product Code FDI
UDI-Device Identifier08714729501657
UDI-Public08714729501657
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 11/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/29/2023
Device Model NumberM00562422
Device Catalogue Number6242-40
Device Lot Number0025124995
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/27/2020
Date Manufacturer Received11/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-