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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPTIFLEX; SNARE, FLEXIBLE
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BOSTON SCIENTIFIC CORPORATION CAPTIFLEX; SNARE, FLEXIBLE Back to Search Results
Model Number M00562402
Device Problems Failure to Deliver Energy (1211); Entrapment of Device (1212)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 05/10/2019
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 medium oval flexible snare was used to remove a large polyp during a colonoscopy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, it was noted that during the removal of a large 30cm polyp, the cautery failed.Reportedly, the snare was securely attached to the active cord and there were no visible issues noted with the cautery pin.The cord, machine, and foot pedal were replaced, however, the snare was still unable to deliver energy.When attempting to remove the snare, the snare loop got stuck within the polyp tissue and was unable to be removed.The physician tried to release the snare multiple times but ended up removing it forcefully, which caused some bleeding.A second captiflex snare was used to stop the bleeding and complete removal of the polyp.There were no long term injury reported as a result of this event.The patient condition following the procedure was reported to be stable.
 
Manufacturer Narrative
User facility reference number: (b)(4).Problem code 1212 captures the reportable event of snare loop embedded in patient tissue.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 medium oval flexible snare was used to remove a large polyp during a colonoscopy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, it was noted that during the removal of a large 30cm polyp, the cautery failed.Reportedly, the snare was securely attached to the active cord and there were no visible issues noted with the cautery pin.The cord, machine, and foot pedal were replaced, however, the snare was still unable to deliver energy.When attempting to remove the snare, the snare loop got stuck within the polyp tissue and was unable to be removed.The physician tried to release the snare multiple times but ended up removing it forcefully, which caused some bleeding.A second captiflex snare was used to stop the bleeding and complete removal of the polyp.There were no long term injury reported as a result of this event.The patient condition following the procedure was reported to be stable.
 
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Brand Name
CAPTIFLEX
Type of Device
SNARE, FLEXIBLE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key8687020
MDR Text Key147602454
Report Number3005099803-2019-02759
Device Sequence Number1
Product Code FDI
UDI-Device Identifier08714729501640
UDI-Public08714729501640
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 06/12/2019
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 Date10/21/2021
Device Model NumberM00562402
Device Catalogue Number6240-40
Device Lot Number0022827738
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/21/2019
Initial Date FDA Received06/11/2019
Supplement Dates Manufacturer Received05/21/2019
Supplement Dates FDA Received06/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age53 YR
Patient Weight111
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