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

Model Number M00562301

Device Problems Failure to Deliver Energy (1211); Failure to Cut (2587)

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

Event Date 10/05/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a captivator small oval stiff snare used to remove multiple gastric polyps in the gastric body during endoscopic mucosal resection (emr) procedure performed on (b)(6) 2022.During the procedure and inside the patient, the physician found that the mucosa of the gastric body was slightly congested with blood through painless gastroscopy and multiple polyp-like bulges were seen, which were removed with a captivator single-use polypectomy snare and cold extraction.During the treatment, the snare was put into the patient's body through the endoscopic channel for polyp removal.During the removal process, it was found that the device had no conductive effect and could not play the role of polyp removal.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.

Manufacturer Narrative

The complainant was unable to provide the suspected device lot number; therefore, the lot expiration and device manufacture dates are unknown.The reported (b)(6).(b)(4).

• 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: 15770406
• MDR Text Key: 307509557
• Report Number: 3005099803-2022-06533
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729019312
• UDI-Public: 08714729019312
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: Other
• Type of Report: Initial
• Report Date: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2022
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Male