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

Model Number M00562301

Device Problem Failure to Cut (2587)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/18/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a050702 captures the reportable event of unable to cut.

Event Description

It was reported to boston scientific corporation that a captivator small oval stiff snare was used during an endoscopic mucosal resection procedure performed on (b)(6), 2023.During the procedure, when attempting to remove the polyp, it was not possible to make incisions.The procedure was completed with a different device.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that a captivator small oval stiff snare was used during an endoscopic mucosal resection procedure performed on (b)(6) 2023.During the procedure, when attempting to remove the polyp, it was not possible to make incisions.The procedure was completed with a different device.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: imdrf device code a050702 captures the reportable event of unable to cut.Block h10 investigation results: one captivator snare was received for analysis.Visual, microscope, functional and electrical analysis of the returned device found no device problems.No other device problems were noted.The reported event of "loop failure to cut" could not be confirmed, as it was not possible to evaluate the device's function during the specific procedure.Device analysis found no device problems.It is most likely that during manipulation of the device an excess of force was applied to the device.Therefore, based on analysis of the returned device and all available information, the most probable cause for the reported event is no problem detected.

• 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: 17756907
• MDR Text Key: 323519141
• Report Number: 3005099803-2023-04758
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729019312
• UDI-Public: 08714729019312
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00562301
• Device Catalogue Number: 6230
• Device Lot Number: 0031764758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2023
• 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