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

Model Number M00562321

Device Problem Failure to Cut (2587)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 08/04/2023

Event Type  Injury  

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 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
• 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: 17649631
• MDR Text Key: 322258249
• Report Number: 3005099803-2023-04496
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729019336
• UDI-Public: 08714729019336
• 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: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00562321
• Device Catalogue Number: 6232
• Device Lot Number: 0030121658
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2022
• 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): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male