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

Model Number M00561191

Device Problems Electrical /Electronic Property Problem (1198); Failure to Cut (2587)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis; 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

Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2020-05064 for the associated device information.It was reported to boston scientific corporation that a captivator ii-25mm round stiff snare was used to remove polyps during a polypectomy procedure performed on (b)(6) 2020.According to the complainant, during the procedure and inside the patient, the first snare worked upon first cut but then failed to cauterize upon further attempts.The generator was switched for another and the same snare was used, but did not result in a successful cut.A second captivator snare with the same size was opened and it worked for two cuts but then, it also failed after.A third captivator snare of a different size was then used successfully to complete the procedure.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.

• Brand Name: CAPTIVATOR II
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 2546 calle primera; propark, coyol; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 10791228
• MDR Text Key: 214762176
• Report Number: 3005099803-2020-05065
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729855934
• UDI-Public: 08714729855934
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K133987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2023
• Device Model Number: M00561191
• Device Catalogue Number: 6119
• Device Lot Number: 0025195593
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1