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

Model Number M00561221

Device Problems Electrical /Electronic Property Problem (1198); Entrapment of Device (1212)

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

Event Date 12/01/2021

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.The complainant was unable to provide the lot number of the suspect device.Therefore, the manufacture and expiration dates are unknown.This event was reported by the distributor.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 in the colon during a colonic polypectomy procedure performed on an unknown date.It was reported that during the procedure and inside the patient, there were problems with device energization.It was ensured that the active cord was connected to the snare and there was no abnormal appearance on the ablation pin.There were signs of blanching.The physician did not attempt to cold cut the polyp.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 e1: this event was reported by the distributor.The reported healthcare facility is: (b)(6) hospital.(b)(6).Phone number: (b)(6).Fax number: (b)(6).Block h6: problem code a07 captures the reportable event of device delivers energy intermittently.Problem code a150208 captures the reportable event of snare loop entrapment.Block h10: the device has been received for analysis; however, the analysis has not yet been completed.Upon 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.Block h11: blocks b1, b2, b5, h1, h6 (patient codes and device codes) and h10 have been updated based on the additional information received.

Event Description

It was reported to boston scientific corporation that a captivator ii-10mm round stiff snare was used in the colon during a colonic polypectomy procedure performed on an unknown date.It was reported that during the procedure and inside the patient, there were problems with device energization.It was ensured that the active cord was connected to the snare and there was no abnormal appearance on the ablation pin.There were signs of blanching.The physician did not attempt to cold cut the polyp.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.Additional information received on january 18, 2022 and february 15, 2022: it was reported that there was energization at first and the snare loop got embedded in the target area.No visible problem was noted with the cautery pin.

Event Description

It was reported to boston scientific corporation that a captivator ii-10mm round stiff snare was used in the colon during a colonic polypectomy procedure performed on an unknown date.It was reported that during the procedure and inside the patient, there were problems with device energization.It was ensured that the active cord was connected to the snare and there was no abnormal appearance on the ablation pin.There were signs of blanching.The physician did not attempt to cold cut the polyp.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.Additional information received on january 18, 2022 and february 15, 2022: it was reported that there was energization at first and the snare loop got embedded in the target area.No visible problem was noted with the cautery pin.

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 e1: this event was reported by the distributor.The reported healthcare facility is: (b)(6) hospital (b)(6).Block h6: problem code a07 captures the reportable event of device delivers energy intermittently.Problem code a150208 captures the reportable event of snare loop entrapment.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 the device contracted and extended well.Electrical test was performed and the device passed, indicating a proper connection.No other problems were noted.The reported event of "device delivers energy intermittently" was not confirmed since the device passed the electrical resistance test upon return.The reported event of "loop entrapment of device" could not be confirmed since the device cannot be functionally evaluated with respect to anatomical/procedural factors encountered during the procedure.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 test.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is no problem detected.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.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: 13258770
• MDR Text Key: 286730730
• Report Number: 3005099803-2022-00114
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729855903
• UDI-Public: 08714729855903
• 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,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2022
• 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: 0027991439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2021
• 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