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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 M00562401
Device Problems Break (1069); Failure to Cut (2587); Material Twisted/Bent (2981)
Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001); Tissue Damage (2104); No Code Available (3191)
Event Date 09/24/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). The device has not been received for analysis. Upon receipt and 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
Note: this report pertains to one of two devices used during the same procedure. Refer to manufacturer report # 3005099803-2020-04816 and 3005099803-2020-04817 for the associated device information. It was reported to boston scientific corporation that two captiflex medium oval flexible snares were used during a colonoscopy with polypectomy procedure performed on (b)(6) 2020. According to the complainant, during the procedure, a six (6) cm pedunculate polyp was partially removed with the first snare using cautery over a saline pillow in the sigmoid colon. The first snare could not cut through the entire polyp due to thickness and size of the polyp stalk. The device became embedded in the polyp tissue and could not be retrieved in a normal fashion. The scope was removed from the patient after the proximal lock of the snare was cut using wire cutter. Then the sheath of snare was removed and a second snare was used in an attempt to retrieve the embedded snare and remove the remaining polyp. After few attempts, it was decided to call off the procedure and send the patient to surgery for the removal of the remaining snare and polyp and also to repair the perforation and hemorrhage. Reportedly, both snares were bent and broken at the handle. The embedded snare was successfully removed surgically however the patient's current condition is unavailable.
 
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Brand NameCAPTIFLEX
Type of DeviceSNARE, FLEXIBLE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC DE COSTA RICA S.R.L.
2546 calle primera
propark, coyol
alajuela
CS
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key10718271
MDR Text Key212521861
Report Number3005099803-2020-04816
Device Sequence Number1
Product Code FDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131700
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM00562401
Device Catalogue Number6240
Device Lot Number0024873082
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/27/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/04/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/22/2020 Patient Sequence Number: 1
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