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

Model Number M00561221

Device Problems Retraction Problem (1536); Failure to Cut (2587)

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

Event Date 11/01/2021

Event Type  malfunction  

Manufacturer Narrative

The exact date of the event is unknown.The provided event date of (b)(6) 2021 was chosen as a best estimate based on the date that the manufacturer became aware of the event.(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a captivator ii-10mm round stiff snare was used to remove a polyp in the colon during a polypectomy procedure performed on an unknown date.It was reported that during the procedure and inside the patient, snare would not cut properly.There was an attempt to apply cautery but the snare shape was not right when closed.The snare was securely attached to the active cord and no visible problems were noted with the cautery pin.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block b3: the exact date of the event is unknown.The provided event date of (b)(6) 2021 was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block h6: problem code a050702 captures the reportable event of snare loop cutting problems.Block h10: investigation results: a captivator ii-10mm round stiff snare was received for analysis.Visual inspection of the returned device revealed that no problems had been found.Functional inspection was performed and device contracted and extended well.Electrical test was performed and the device passed, indicating a proper connection.No other problems were noted.The reported complaint of loop failure to cut could not be confirmed since the device cannot be functionally evaluated with respect to anatomical/procedural factors encountered during the procedure.The reported complaint of loop retraction problem was not confirmed due to the loop contracted and extended without problems.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 tests.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is no problem detected.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

Event Description

It was reported to boston scientific corporation that a captivator ii-10mm round stiff snare was used to remove a polyp in the colon during a polypectomy procedure performed on an unknown date.It was reported that during the procedure and inside the patient, snare would not cut properly.There was an attempt to apply cautery but the snare shape was not right when closed.The snare was securely attached to the active cord and no visible problems were noted with the cautery pin.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.

• 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: 12961530
• MDR Text Key: 286010454
• Report Number: 3005099803-2021-06356
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729855903
• UDI-Public: 08714729855903
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2021
• 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: 0027598697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2021
• 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