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

Model Number M00562321

Device Problem Failure to Deliver Energy (1211)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/11/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).

Event Description

It was reported to boston scientific corporation that a captivator medium oval stiff snare was used during an unknown procedure performed on (b)(6) 2022.During the procedure and inside the patient, when the nurse used the snare for thermal cutting, it was found that the device could not conduct electricity.After the wound cutting for the patient, electric cautery and blood coagulation didn't work and there was bleeding of the wound.The physician closed the wound with a titanium clip.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 oval stiff snare was used during an unknown procedure performed on (b)(6) 2022.During the procedure and inside the patient, when the nurse used the snare for thermal cutting, it was found that the device could not conduct electricity.After the wound cutting for the patient, electric cautery and blood coagulation didn't work and there was bleeding of the wound.The physician closed the wound with a titanium clip.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.Additional information received on december 26, 2022: the snare was used to remove a 1.8 - 2cm size of polyp in the sigmoid flexure during an electro resection by colonoscopy procedure.The patient did not have any history of coagulopathy/bleeding disorders and the patient was not on any anticoagulants.The snare was securely attached to the active cord and there were no visible problems noted with the cautery pins.

Manufacturer Narrative

Block e1: the reported health care facility: (b)(6).The reported health care facility's address is no.: (b)(6).Block h6: imdrf device code a090402 captures the reportable event of snare unable to deliver energy.Block h11: blocks b5, d7a, and e1 (initial reporter zip/post code and initial reporter phone) have been updated based on the additional information received on december 26, 2022.

• Brand Name: CAPTIVATOR
• 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: 16013652
• MDR Text Key: 307030315
• Report Number: 3005099803-2022-07518
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729019336
• UDI-Public: 08714729019336
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K131700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00562321
• Device Catalogue Number: 6232
• Device Lot Number: 0029216329
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male