MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPTIVATOR II; SNARE, FLEXIBLE

Model Number	M00561192
Medical Device Problem Codes	Retraction Problem (1536); Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a captivator ii-25mm round stiff snare was used during a colonoscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the snare did not feel or appear to be cutting the tissue adequately.Also, the snare did not retract into the catheter fully when trying to close the handle.It was reported that the procedure was completed, however it was not reported how the procedure was completed.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Event or Problem Description
It was reported to boston scientific corporation that a captivator ii-25mm round stiff snare was used during a colonoscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the snare did not feel or appear to be cutting the tissue adequately.Also, the snare did not retract into the catheter fully when trying to close the handle.It was reported that the procedure was completed, however it was not reported how the procedure was completed.There were no patient complications reported as a result of this event.***additional information received on (b)(6) 2020*** there were no other issues noted with the device.The procedure was completed with a different device which was one of the legacy models of the snare.The patient's condition at the conclusion of the procedure was reported to be fine.
Additional Manufacturer Narrative
Block h6: problem code 2587 captures the reportable event of snare loop failure to cut.Conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.Block h10: according to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental medwatch will be filed.Block h11: blocks b5 and h2 have been updated based on the additional information received on august 06, 2020.

• Brand Name: CAPTIVATOR II
• Common Device Name: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10364125
• Report Number: 3005099803-2020-03091
• Device Sequence Number: 14214039
• Product Code: FDI
• UDI-Device Identifier: 08714729861270
• UDI-Public: 08714729861270
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K133987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/12/2023
• Device Model Number: M00561192
• Device Catalogue Number: 50296
• Device Lot Number: 0025351476
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/17/2020
• Supplement Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 08/04/2020
• Supplement Report FDA Received Date: 08/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1