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

Model Number M00562341

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: the exact date of the event is unknown.The provided event date of (b)(6) 2020 was chosen as a best estimate based on the date that the manufacturer became aware of the event.(b)(4).The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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

It was reported to boston scientific corporation that a captivator medium hexagonal stiff snare was used during a polypectomy procedure performed on an unknown date.According to the complainant, during the procedure, the snare would not cut the target polyp.The physician troubleshoot the device by opening and closing it again.However, the issue was not resolved.The procedure was completed with a different device.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.

Manufacturer Narrative

Block b3: the exact date of the event is unknown.The provided event date of (b)(6) 2020 was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block h6: problem code 2587 captures 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: block b5 has been updated with additional information received on october 28, 2020.Blocks h6 and h10 have been updated based on investigation closure for device not returned.

Event Description

It was reported to boston scientific corporation that a captivator medium hexagonal stiff snare was used during a polypectomy procedure performed on an unknown date.According to the complainant, during the procedure, the snare would not cut the target polyp.The physician troubleshoot the device by opening and closing it again.However, the issue was not resolved.The procedure was completed with a different device.There were no patient complications reported as a result of this event.According to the complainant, the snare loop did not fully retract inside the cannula.There were no other issues noted with the device.The patient's condition at the conclusion of the procedure was reported to be fine.

• Brand Name: CAPTIVATOR
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10682987
• MDR Text Key: 211458989
• Report Number: 3005099803-2020-04573
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729019350
• UDI-Public: 08714729019350
• Combination Product (y/n): N
• PMA/PMN Number: K131700
• 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: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/09/2023
• Device Model Number: M00562341
• Device Catalogue Number: 6234
• Device Lot Number: 0025185062
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/12/2020
• Date Manufacturer Received: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1