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

Model Number M00561223

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 08/28/2023

Event Type  Injury  

Manufacturer Narrative

Block h6: imdrf device code a0501 captures the reportable event of loop detached.

Event Description

It was reported to boston scientific corporation that a 10mm captivator ii round stiff snare was used during a colonoscopy procedure performed on (b)(6) 2023.The polyp was in the transverse colon with a size of less than 9mm.During the procedure, when deploying the snare to remove the polyp in the transverse colon, the snare detached and fell into the patient's body.The snare loop was successfully retrieved without injury to the patient.The procedure was completed with a similar 10mm captivator ii round stiff snare.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that a 10mm captivator ii round stiff snare was used during a colonoscopy procedure performed on (b)(6) 2023.The polyp was in the transverse colon with a size of less than 9mm.During the procedure, when deploying the snare to remove the polyp in the transverse colon, the snare detached and fell into the patient's body.The snare loop was successfully retrieved without injury to the patient.The procedure was completed with a similar 10mm captivator ii round stiff snare.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: imdrf device code a0501 captures the reportable event of loop detached.Block h10 investigation results: one captivator snare was received for analysis.Visual and microscope analysis of the returned device found the loop was detached from the wire and the snare loop was not returned.No other device problems were noted.The reported event of "loop detached" is confirmed since the loop detached from wire and was not returned.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 the loop was detached during visual and microscope test.Based on the analysis of the returned device and the information available, the code selected as the most probable root cause is manufacturing deficiency.This code was selected since it was found the loop was disconnected from the wire.An investigation is in place to address this problem.

• 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 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: 17777216
• MDR Text Key: 323768236
• Report Number: 3005099803-2023-04846
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729861317
• UDI-Public: 08714729861317
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00561223
• Device Catalogue Number: 50297
• Device Lot Number: 0031650026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2023
• 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 Outcome(s): Required Intervention