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

Model Number	M00562371
Medical Device Problem Codes	Retraction Problem (1536); Failure to Cut (2587)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2021
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 medium crescent stiff snare was used during a colonoscopy procedure performed on (b)(6) 2021.According to the complainant, during the procedure, the snare would not close all the way.The technician described that the snare was felt flimsy and had difficulty resecting the target polyp.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a captivator medium cresent stiff snare was used during a colonoscopy procedure performed on (b)(6) 2021.According to the complainant, during the procedure, the snare would not close all the way.The technician described that the snare was felt flimsy and had difficulty resecting the target polyp.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.It was reported that they were having issues with the snares not cutting through polyps causing clips to be replaced at the polyp site to stop the bleeding.
Additional Manufacturer Narrative
Block g2: report source (user facility) maude report mw5099149 received on march 01, 2021.Block h6: problem code a050702 captures the reportable event of loop difficulty resecting the target polyp.Conclusion code d17 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 and h6 (patient codes, impact codes) have been updated with the additional information based on maude report mw5099149 received on march 01, 2021.

• Brand Name: CAPTIVATOR
• Common Device Name: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11323017
• Report Number: 3005099803-2021-00435
• Device Sequence Number: 4274660
• Product Code: FDI
• UDI-Device Identifier: 08714729019381
• UDI-Public: 08714729019381
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K131700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2021

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: 10/11/2023
• Device Model Number: M00562371
• Device Catalogue Number: 6237
• Device Lot Number: 0026130915
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/25/2021
• Supplement Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 02/12/2021
• Supplement Report FDA Received Date: 03/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1