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

Model Number M00562391

Device Problems Failure to Deliver Energy (1211); Failure to Cut (2587)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); No Code Available (3191)

Event Date 08/05/2020

Event Type  Injury  

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 # 3005099803-2020-03571 and 3005099803-2020-03572 for the associated device information.It was reported to boston scientific corporation that a captivator lg oval thin wire snare was used during a colonoscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the snare was tested outside the patient and it worked fine.While used inside the patient, the device was unable to achieve cautery and was unsuccessful in resecting the target polyp.A second device was used, however, it encountered the same issue.Reportedly, the patient experienced bleeding and hematoma.Since the mass could not be resected at the outpatient center, the patient was referred to the hospital for surgery to remove the mass at a later date.The bleeding was not the reason for the referral.There were no other interventions performed or treatment provided for the patient.It is unknown if the surgery to remove the mass has been performed.The patient's current condition was reported to be okay.

• 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: 10466385
• MDR Text Key: 204768331
• Report Number: 3005099803-2020-03571
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729019404
• UDI-Public: 08714729019404
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/10/2022
• Device Model Number: M00562391
• Device Catalogue Number: 6239
• Device Lot Number: 0024091292
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/05/2020
• Initial Date FDA Received: 08/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2019
• 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 Outcome(s): Required Intervention