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

Model Number M00561192

Device Problems Retraction Problem (1536); Failure to Cut (2587)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/17/2020

Event Type  malfunction  

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 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 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.

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
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10364125
• MDR Text Key: 208797951
• Report Number: 3005099803-2020-03091
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729861270
• UDI-Public: 08714729861270
• Combination Product (y/n): N
• PMA/PMN Number: K133987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 07/17/2020
• Initial Date FDA Received: 08/04/2020
• Supplement Dates Manufacturer Received: 08/06/2020
• Supplement Dates FDA Received: 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1