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

Model Number M00561291

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 11/24/2021

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a captivator extra large round stiff snare was used during an endoscopic mucosal resection (emr) procedure performed on (b)(6) 2021.During preparation and outside the patient, the cautery pin was detached.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.

Manufacturer Narrative

This event was reported by the distributor.The reported healthcare facility information is: (b)(6).(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Manufacturer Narrative

Block e1: this event was reported by the distributor.The reported healthcare facility information is: (b)(6).Block h6: problem code a0501 captures the reportable event of cautery pin detached.Block h10: (product investigation): one captivator snare was received for analysis.Visual analysis of the returned device noted that the cautery pin was broken inside of the original sealed pouch.The reported event of "cautery pin detached" was confirmed since the cautery pin was noted to be broken inside of the original sealed pouch.Based on the analysis of the returned device and the information available, the code selected as the most probable cause is manufacturing deficiency.There is an investigation in place to address this problem.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 extra large round stiff snare was used during an endoscopic mucosal resection (emr) procedure performed on (b)(6) 2021.During preparation and outside the patient, the cautery pin was detached.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block e1: this event was reported by the distributor.The reported healthcare facility information is: (b)(6).Block h6: problem code a0501 captures the reportable event of cautery pin detached.Block h10: (product investigation): one captivator snare was received for analysis.Visual analysis of the returned device noted that the cautery pin was broken inside of the original sealed pouch.The reported event of "cautery pin detached" was confirmed since the cautery pin was noted to be broken inside of the original sealed pouch.Based on the analysis of the returned device and the information available, the code selected as the most probable cause is design inadequate for purpose.There is an investigation in place to address this problem.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.Block h11: blocks h6 (evaluation conclusion code) and h10 have been corrected.

Event Description

It was reported to boston scientific corporation that a captivator extra large round stiff snare was used during an endoscopic mucosal resection (emr) procedure performed on (b)(6) 2021.During preparation and outside the patient, the cautery pin was detached.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.

• 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: 13051387
• MDR Text Key: 282557158
• Report Number: 3005099803-2021-06350
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729645801
• UDI-Public: 08714729645801
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/15/2024
• Device Model Number: M00561291
• Device Catalogue Number: 6129
• Device Lot Number: 0027150732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2021
• 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