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

Model Number M00562451

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 09/15/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to boston scientific corporation that a captivator small hexagonal stiff snare was prepared for use to remove polyps in the colon during an endoscopic colorectal polypectomy procedure performed on (b)(6) 2022.During preparation and outside the patient, the cautery pin was loose/disconnected.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: medical device code a0501 captures the reportable event of cautery pin detached.Block h10: (product investigation) one captivator snare was received for analysis.Visual inspection of the returned device found no problems.The 2 in 1 connector did not have any problems.Microscopic test of the 2 in 1 connector found no damages.No other problems with the device were noted.The reported event of "cautery pin detached" could not be confirmed since no problems were noted with the 2 in 1 connector during visual and microscopic test.Based on the analysis of the returned device and the information available, the code selected as the most probable cause is no problem detected.

Event Description

It was reported to boston scientific corporation that a captivator small hexagonal stiff snare was prepared for use to remove polyps in the colon during an endoscopic colorectal polypectomy procedure performed on (b)(6) 2022.During preparation and outside the patient, the cautery pin was loose/disconnected.The procedure was completed with another captivator snare.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: 15620690
• MDR Text Key: 301919545
• Report Number: 3005099803-2022-05957
• Device Sequence Number: 1
• Product Code: FDI
• 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: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00562451
• Device Catalogue Number: 6245
• Device Lot Number: 0029411034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2022
• 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