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

Model Number M00561221

Device Problems Mechanical Problem (1384); Difficult to Open or Close (2921); Device Contamination with Chemical or Other Material (2944)

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

Event Date 11/30/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a captivator ii-10mm round stiff snare was used during a colonic polypectomy procedure performed on (b)(6) 2022.During the procedure and inside the patient, when technician implants the snare into patient, they found some foreign matter like cottonwool in the snare, and it couldn't open smoothly.The procedure was completed with another same of the device.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Block h6: imdrf device code a180104 captures the reportable event of foreign material present in device.

Event Description

It was reported to boston scientific corporation that a captivator ii-10mm round stiff snare was used during a colonic polypectomy procedure performed on (b)(6) 2022.During the procedure and inside the patient, when technician implants the snare into patient, they found some foreign matter like cottonwool in the snare, and it couldn't open smoothly.The procedure was completed with another same of the device.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.There was no damage noticed with the inner sterile pouch and the inner seal package was not compromised.The snare would not open completely and there were no visible problems with the handle.

Manufacturer Narrative

Block h6: imdrf device code a180104 captures the reportable event of foreign material present in device.Investigation results: a captivator ii-10mm round stiff snare was received for analysis.Visual and microscope inspection of the returned device revealed a foreign material like filament around the loop.Functional testing was performed, and the loop could extend and retract well.A destructive test was performed, the device was disassembled, and a broken wire was observed and there were friction marks in the working length.No other problems were noted.The reported complaint of loop unable to extend was not confirmed since the device could extend completely.The reported complaint of foreign material present in the device was confirmed since during product analysis, they found a filament like foreign material inside the device.Additionally, a broken wire was found at the cannula and friction marks were found in the working length.An investigation to address this problem concluded that the broken wire was scratching the internal surfaces of the catheter and generated the fibrous residues, which were reported as foreign material.The investigation concluded that the most likely cause of the event is manufacturing deficiency, and that this is considered an isolated event.

Event Description

It was reported to boston scientific corporation that a captivator ii-10mm round stiff snare was used during a colonic polypectomy procedure performed on (b)(6) 2022.During the procedure and inside the patient, when technician implants the snare into patient, they found some foreign matter like cottonwool in the snare, and it couldn't open smoothly.The procedure was completed with another same of the device.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.Additional information received on december 27, 2022.There was no damage noticed with the inner sterile pouch and the inner seal package was not compromised.The snare would not open completely and there were no visible problems with the handle.

• 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: 16023205
• MDR Text Key: 306455137
• Report Number: 3005099803-2022-07653
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729855903
• UDI-Public: 08714729855903
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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,Followup
• Report Date: 02/27/2023

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: M00561221
• Device Catalogue Number: 6122
• Device Lot Number: 0029644859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2022
• 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