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

Model Number M00562371

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

Patient Problems Hemorrhage/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/25/2021

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 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 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.

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
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11323017
• MDR Text Key: 231651642
• Report Number: 3005099803-2021-00435
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729019381
• UDI-Public: 08714729019381
• 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: 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
• Device Operator: 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 Manufacturer Received: 01/25/2021
• Initial Date FDA Received: 02/12/2021
• Supplement Dates Manufacturer Received: 03/01/2021
• Supplement Dates FDA Received: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1