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

Model Number	M00562391
Medical Device Problem Codes	Failure to Deliver Energy (1211); Failure to Cut (2587)
Health Effect - Clinical Codes	Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888); No Code Available (3191)
Date of Event	08/05/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10466385
• Report Number: 3005099803-2020-03571
• Device Sequence Number: 2642710
• Product Code: FDI
• UDI-Device Identifier: 08714729019404
• UDI-Public: 08714729019404
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K131700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 08/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention