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

Model Number 6123

Device Problem Retraction Problem (1536)

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

Event Date 12/05/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to boston scientific corporation that a 15mm captivator ii round snare was used during a polypectomy procedure performed in ascending colon on (b)(6) 2022.During the procedure, snaring was performed with the device when the loop suddenly retracted into the sheath.The procedure was completed with a similar captivator ii snare.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that a 15mm captivator ii round snare was used during a polypectomy procedure, performed in the ascending colon on (b)(6) 2022.During the procedure, snaring was performed with the device when the loop suddenly retracted into the sheath.The procedure was completed with a similar captivator ii snare.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Problem code a0510 captures the reportable event of loop retracted suddenly.(product investigation): one captivator snare was received for analysis.Visual analysis of the returned device found no device problems.Functional evaluation of the returned device found that when the device was connected to the 10-inch loop fixture, it contracted and extended well.The reported event of "loop retracted suddenly" could not be confirmed since could since no issues were noted during functional test.The product record review confirmed that this was not a new failure type, and the risk was anticipated.There was no evidence of a manufacturing problem, design or user problem which could have caused the complaint.Device analysis found no problems with the device during visual and functional.Based on the analysis of the returned device and the information available, the code selected as the most probable cause is no problem detected.This code was selected since the reported event could not be confirmed.

• Brand Name: CAPTIVATOR II
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; propark, coyol; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16013345
• MDR Text Key: 308363072
• Report Number: 3005099803-2022-07404
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729855910
• UDI-Public: 08714729855910
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133987
• 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: 02/10/2023

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: 6123
• Device Catalogue Number: 6123
• Device Lot Number: 0028715642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2022
• Initial Date FDA Received: 12/20/2022
• Supplement Dates Manufacturer Received: 01/21/2023
• Supplement Dates FDA Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2022
• 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