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

Model Number M00562301

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 03/10/2022

Event Type  malfunction  

Manufacturer Narrative

The initial reporter fax number is (b)(6).Problem code: (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 small oval stiff snare was used during a polypectomy procedure performed on (b)(6) 2022.During preparation and outside the patient, it was noted that the snare loop of the device was detached from the plastic sheath.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: the initial reporter fax number is (b)(6).Block h6: problem code a0501 captures the reported event of snare loop detached.Block h10: (product investigation): one captivator snare was received for analysis.Visual analysis of the returned device revealed that the working length was twisted/kinked, ripped and the internal wire was kinked.The loop was attached to the wire inside of the working length.During microscope inspection, it was noted that the working length was twisted/kinked, ripped and the internal wire was kinked.Functional test could not be performed due to the condition of the device.The reported event of "loop detached" could not be confirmed since the loop was attached to the wire inside of the working length.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 that the working length was twisted/kinked, ripped, and the internal wire was kinked.This could occur during manipulation of the device during the removal of the pouch or preparation.Most likely handling of the device or the technique used by the physician during initial use lead to the reported event.Based on the analysis of the returned device and the information available, the code selected as the most probable cause is adverse event related to procedure.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 during a polypectomy procedure performed on (b)(6) 2022.During preparation and outside the patient, it was noted that the snare loop of the device was detached from the plastic sheath.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: 13956523
• MDR Text Key: 288285239
• Report Number: 3005099803-2022-01657
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/03/2022

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: 06/02/2022
• Device Model Number: M00562301
• Device Catalogue Number: 6230
• Device Lot Number: 0023891772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2022
• Initial Date FDA Received: 03/30/2022
• Supplement Dates Manufacturer Received: 04/07/2022
• Supplement Dates FDA Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2019
• 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: 51 YR
• Patient Sex: Female
• Patient Weight: 60 KG