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

Model Number M00561221

Device Problems Mechanical Problem (1384); Failure to Cut (2587)

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

Event Date 09/14/2021

Event Type  malfunction  

Manufacturer Narrative

This event was reported by the dealer.The reported healthcare facility is: (b)(6).(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 fundus of stomach during a polyp snare procedure performed on (b)(6) 2021.It was reported that during the procedure and inside the patient, when the device was deployed, it was found that it was not round enough to reach the round state of the picture on the outer package, and it was not sharp enough to cut the small polyps.Reportedly, there were no issues noted in the handle.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.

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 fundus of stomach during a polyp snare procedure performed on (b)(6) 2021.It was reported that during the procedure and inside the patient, when the device was deployed, it was found that it was not round enough to reach the round state of the picture on the outer package, and it was not sharp enough to cut the small polyps.Reportedly, there were no issues noted in the handle.The procedure was completed with another captivator snare.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

Block e1: this event was reported by the dealer.The reported healthcare facility is: (b)(6) hospital.Block h6: problem code a050702 captures the reportable event of snare loop unable to cut.Block h10: investigation results a captivator ii-10mm round stiff snare was received for analysis.Visual inspection of the returned device revealed that the catheter, loop and handle were in good conditions and no damages were found.Functional inspection was performed and when the device was connected to the 10 inch loop fixture, it contracted and extended without problems.Dimensional inspection was performed and the device passed within the model specified in the drawing.Electrical test was performed and the device passed, indicating a proper connection.No other problems were noted.The reported event of "loop failure to cut" was not confirmed since the device cannot be functionally evaluated with respect to anatomical/procedural factors encountered during the procedure.The reported event of "loop failure to extend" was not confirmed, since the device extended and retracted well and the device passed dimensional inspection.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, functional, dimensional, and electrical testing.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is no problem detected.This code was selected as the most probable complaint cause since the reported events cannot be confirmed.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

• 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: 12591114
• MDR Text Key: 275204764
• Report Number: 3005099803-2021-05172
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729855903
• UDI-Public: 08714729855903
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• 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: 0027150488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2021
• 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
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 46 KG