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

Model Number M00562301

Device Problems Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)

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

Event Date 09/30/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a captivator small oval stiff snare was used during an endoscopic mucosal resection (emr) procedure performed on (b)(6) 2022.During the procedure and outside the patient, the cautery pin was detached, and the width of the pin was closed.The connection terminal was loose and could not be connected.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Device manufacture date: the complainant was unable to provide the lot number of the suspect device.Therefore, the manufacture and expiration dates are unknown.Problem code a0501 captures the reportable event of cautery pin detached.

Manufacturer Narrative

Block h11: blocks b5 and h6 have been updated based on additional information received on november 23, 2022.

Event Description

It was reported to boston scientific corporation that a captivator small oval stiff snare was used during an endoscopic mucosal resection (emr) procedure performed on (b)(6) 2022.During the procedure and outside the patient, the cautery pin was detached, and the width of the pin was closed.The connection terminal was loose and could not be connected.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.Additional information received on november 23, 2022: the cautery pin was still connected to the snare but wouldn't connect to the active cord.

• 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: 15670359
• MDR Text Key: 306886741
• Report Number: 3005099803-2022-06211
• 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: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 0029714357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2022
• Initial Date FDA Received: 10/25/2022
• Supplement Dates Manufacturer Received: 11/02/2022
• Supplement Dates FDA Received: 11/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2022
• 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