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

Model Number M00562301

Device Problems Electrical /Electronic Property Problem (1198); Failure to Cut (2587)

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

Event Date 09/12/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a captivator small oval stiff snare was used during an endoscopic polypectomy procedure performed on (b)(6) 2022.During the procedure and inside the patient, the snare was used multiple times to remove the polyp, it showed poor conduction, and the polyp could not be completely removed.The procedure was completed with another brand of snare.No further information has been obtained despite good faith efforts.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Block h6: imdrf device code a07 captures the reportable event of suboptimal cautery.Imdrf device code a050702 captures the reportable event of snare loop cutting problems.Block e1: the reported health care facility's address is no.6-1, nanbinjiang rd, tianma st, changshan county, quzhou city, zhejiang province.Block h11: blocks b5, d7a, e1 (initial reporter title, first name, last name, facility name, address, phone, occupation), f10 (impact code), g2 (report source) have been updated based on the additional information received on december 28, 2022.

Event Description

It was reported to boston scientific corporation that a captivator small oval stiff snare was used during an endoscopic polypectomy procedure performed on (b)(6) 2022.During the procedure and inside the patient, the snare was used multiple times to remove the polyp, it showed poor conduction, and the polyp could not be completely removed.The procedure was completed with another brand of snare.Additional information received on december 28, 2022: the snare was used to remove a 0.5 cm polyp in the intestinal tract during an endoscopic mucosal resection (emr) procedure.The snare was securely attached to the active cord and there were no visible problems noted with the cautery pin.There were no patient complications reported as a result of this event.

• 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: 16026333
• MDR Text Key: 308129389
• Report Number: 3005099803-2022-07654
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• 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
• Device Lot Number: 0028643814
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2022
• 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 Age: 52 YR
• Patient Sex: Female