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

Model Number M00561223

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).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a captivator ii was used during a colonoscopy procedure performed on (b)(6) 2021.According to the complainant, during the procedure, the snare would not close around the polyp or cut the polyp.The procedure was completed with a different snare.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable/fine.

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 failure to cut.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.Blocks b5 and h6 (patient codes, impact codes) have been updated with the additional information based on maude report mw5099149 received on march 01, 2021.

Event Description

It was reported to boston scientific corporation that a captivator ii was used during a colonoscopy procedure performed on (b)(6) 2021.According to the complainant, during the procedure, the snare would not close around the polyp or cut the polyp.The procedure was completed with a different snare.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable/fine.*** additional information received on march 01, 2021 *** 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.

• 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: 11323029
• MDR Text Key: 231650832
• Report Number: 3005099803-2021-00447
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729861317
• UDI-Public: 08714729861317
• 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: 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: 09/03/2023
• Device Model Number: M00561223
• Device Catalogue Number: 50297
• Device Lot Number: 0025959071
• 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