MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION HEXAGONAL SNARE/ERBE CAUTERY UNI; SNARE, FLEXIBLE

Model Number M00562450

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/17/2022

Event Type  Injury  

Event Description

Attempted to cauterize a polyp with erbe cautery machine and boston scientific hexagonal snare.Erbe machine checked by biomed (b)(6) 2022.Green light was on informing that pad was good placement and would be safe to cautery.Cut polyp but cautery failed to cauterize area.Patient from no cautery, developed arterial bleed.Clips applied and epinephrine injected.Patient discharged.Later that evening developed additional bleeding.Admitted to hospital and remobilization procedure performed.Patient discharged after two days.Contacted boston scientific representative, after review of information, new connection cords to snare were replaced on (b)(6) 2022.Snares have been in use since 2017 without any deviation from standard performance.To date have not had any other adverse events with equipment.Fda safety report id #:(b)(4).

• Brand Name: HEXAGONAL SNARE/ERBE CAUTERY UNI
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; marlbourogh MA 01752
• MDR Report Key: 13863243
• MDR Text Key: 287821507
• Report Number: MW5108459
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/21/2022

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 Model Number: M00562450
• Device Lot Number: 28494728
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CAPTIVATOR SMALL HEXAGONAL SNARE
• Patient Outcome(s): Hospitalization
• Patient Age: 54 YR
• Patient Sex: Transgender
• Patient Weight: 135 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White