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

Model Number	M00562321
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	08/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block e1 (initial reporter facility name): (b)(6) hospital.Block e1 (initial reporter address): (b)(6).Block h6: imdrf patient code e2015 captures the reportable event of tissue injury.Imdrf impact code f08 captures the reportable event of hospitalization.Imdrf impact code f23 captures the reportable event of unexpected medical intervention.Imdrf device code a050702 captures the reportable event of unable to cut.
Event or Problem Description
It was reported to boston scientific corporation that a captivator medium oval stiff snare was used during an endoscopic mucosal resection procedure performed on (b)(6) 2023.The lesion was a long mucosal swelling with lobed surface and a size of 1.5 cm.During the procedure, a 27mm snare was used but was unable to cut with repeated attempts for 20 minutes, causing damage to the surrounding mucosa.A hemostatic clip was used for the damage to the surrounding mucosa.The procedure was completed using a non-bsc snare.The patient was hospitalized.The patient's vital signs were closely monitored, and no adverse reactions occurred.The patient has been discharged and the patient's current condition is stable.

• Brand Name: CAPTIVATOR
• Common Device Name: 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: 17649631
• Report Number: 3005099803-2023-04496
• Device Sequence Number: 6331609
• Product Code: FDI
• UDI-Device Identifier: 08714729019336
• UDI-Public: 08714729019336
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K131700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/30/2023

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: 09/09/2025
• Device Model Number: M00562321
• Device Catalogue Number: 6232
• Device Lot Number: 0030121658
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male