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

Model Number M00561231

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

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

Event Date 10/09/2021

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 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

Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2021-05476 for the associated device information.It was reported to boston scientific corporation that a 15mm captivator ii round stiff snare was used in the fundus of the stomach during a polyp removal procedure performed on (b)(6) 2021.During the procedure and inside the patient, it was reported that the snare was not as round as the picture on the outer packaging after the physician deployed the snare.The device was not sharp enough to remove the small polyp.A second captivator snare was also not as round as the picture on the outer packaging after the physician deployed the snare, and was not sharp enough to remove the small polyp.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.

Event Description

Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2021-05474 and 3005099803-2021-05476 for the associated device information.It was reported to boston scientific corporation that a 15mm captivator ii round stiff snare was used in the fundus of the stomach during a polyp removal procedure performed on (b)(6) 2021.During the procedure and inside the patient, it was reported that the snare was not as round as the picture on the outer packaging after the physician deployed the snare.The device was not sharp enough to remove the small polyp.A second captivator snare was also not as round as the picture on the outer packaging after the physician deployed the snare, and was not sharp enough to remove the small polyp.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 returned device noted no device problems.Functional evaluation of the returned device found that when the device was connected to the 10 inch loop fixture, it contracted and extended well.Electrical testing was also performed and the device's electrical resistance was within specification.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 reported event of "loop failure to extend" was not confirmed since the loop was able to contract and extend 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 analysis of the returned device and the information available, the code selected as the most probable cause is no problem detected.This code was selected since the reported events 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.

• 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: 12731490
• MDR Text Key: 279920073
• Report Number: 3005099803-2021-05474
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729855910
• UDI-Public: 08714729855910
• 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: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: M00561231
• Device Catalogue Number: 6123
• Device Lot Number: 0026108096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2020
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 58 KG