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

Model Number M00562301

Device Problem Failure to Cut (2587)

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

Event Date 09/07/2021

Event Type  malfunction  

Manufacturer Narrative

This event was reported by the dealer.The reported physician and healthcare facility information are: (b)(6).(b)(4).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.

Event Description

It was reported to boston scientific corporation that a captivator small oval stiff snare was used in the fundus of stomach during a polypectomy procedure performed on (b)(6) 2021.During the procedure and inside the patient, the physician could not use the device to remove the patient's polyp lesion.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block e1: this event was reported by the dealer.The reported physician and healthcare facility information are: (b)(6) block h6: problem code a050702 captures the reportable event of polyp resecting problem.Block h10: (product investigation) one captivator snare was received for analysis.Visual analysis of the device noted that the working length was bent.Functional evaluation of the returned device found that when the device was connected to the 10 inch loop fixture, it contracted and extended without problems even with the bent noted.Continuity test was also performed and the device's electrical resistance was within specification, indicating a proper connection.The reported event of "loop failure to cut" could not be confirmed since the device cannot be functionally evaluated with respect to the 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.During product analysis it was noted that the working length was bent.This probably happened by an excessive force being applied in the device.Most likely procedural factors such as handling of the device, the technique used by the physician during initial use, set-up, power-up, or shortly thereafter could have affected its condition.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 cause since the reported event of loop failure to cut could not be confirmed.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.

Event Description

It was reported to boston scientific corporation that a captivator small oval stiff snare was used in the fundus of stomach during a polypectomy procedure performed on (b)(6) 2021.During the procedure and inside the patient, the physician could not use the device to remove the patient's polyp lesion.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: CAPTIVATOR
• 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: 12570818
• MDR Text Key: 274765411
• Report Number: 3005099803-2021-05059
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729019312
• UDI-Public: 08714729019312
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K131700
• 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: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/04/2022
• Device Model Number: M00562301
• Device Catalogue Number: 6230
• Device Lot Number: 0024383203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/09/2021
• Initial Date FDA Received: 10/04/2021
• Supplement Dates Manufacturer Received: 10/21/2021
• Supplement Dates FDA Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2019
• 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: 37 YR
• Patient Sex: Male
• Patient Weight: 73 KG