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

Device Problems Failure to Deliver Energy (1211); Material Twisted/Bent (2981)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/26/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a captivator snare was used for a patient with profuse polyposis to remove large polyps (approximately 6cm, oval) during a gastrointestinal procedure performed on (b)(6) 2023.During the procedure and inside the patient, the snare was used with the fuji gastroscope (not dbe device).It was opened in the stomach; the cautery settings were set to standard but upon snaring the polyp there was no cautery effect noted.Therefore, the polyp was removed with forceful traction with a cold snaring approach which was contraindicated for large polyps.The stalk required trimming with hot snare to ensure hemostasis and there as post polypectomy bleeding noted.Then, an endo-coagulopathy device was introduced into the double balloon enteroscope device channel for polyp snare and hemostasis.The device was slightly bent when introduced to the stomach and they began to coil around the polyp.However, electrocautery did not work, and the device could not be removed.The physician had to remove the polyp by using a "cold snared" method.The patient had minimal bleeding and was controlled without additional hemostatic methods.This did cause a delay of case and the procedure was not completed for more than 4 hours.The patient was discharged on the same day and no patient complications were noted.

Manufacturer Narrative

Imdrf device code a090402 captures the reportable event of snare unable to deliver energy.

• 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: 16718430
• MDR Text Key: 313145137
• Report Number: 3005099803-2023-01812
• Device Sequence Number: 1
• Product Code: FDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 13 YR
• Patient Sex: Female
• Patient Weight: 58 KG