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

Model Number M00561291

Device Problems Failure to Deliver Energy (1211); Entrapment of Device (1212)

Patient Problem No Code Available (3191)

Event Date 02/11/2019

Event Type  Injury  

Manufacturer Narrative

The exact age of the patient is unknown.However, it was reported the patient was over 18 years.(b)(4).The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.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.

Event Description

It was reported to boston scientific corporation that a captivator extra large round stiff snare was used during a polypectomy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, after connecting to a generator, the device failed to deliver energy.This failure caused the snare loop to be embedded on the 5mm target polyp.Reportedly, the snare was securely attached to the active cord and there was no visible issues noted with the cautery pin.An endoscopic submucosal dissection (esd) was performed to cut the polyp and to retrieve the embedded snare loop, however, due to the condition of the patient and lack of time, they only cut a part of the polyp.The snare was successfully retrieved.The polypectomy procedure was not completed and the patient was admitted as a result of this event.Another endoscopic submucosal dissection (esd) procedure was performed on (b)(6) 2019 in order to remove the rest of the polyp.The patient condition at the conclusion of the procedure was reported to be stable.

Event Description

It was reported to boston scientific corporation that a captivator extra large round stiff snare was used during a polypectomy procedure performed on (b)(6), 2019.According to the complainant, during the procedure, after connecting to a generator, the device failed to deliver energy.This failure caused the snare loop to be embedded on the 5mm target polyp.Reportedly, the snare was securely attached to the active cord and there was no visible issues noted with the cautery pin.An endoscopic submucosal dissection (esd) was performed to cut the polyp and to retrieve the embedded snare loop, however, due to the condition of the patient and lack of time, they only cut a part of the polyp.The snare was successfully retrieved.The polypectomy procedure was not completed and the patient was admitted as a result of this event.Another endoscopic submucosal dissection (esd) procedure was performed on (b)(6), 2019 in order to remove the rest of the polyp.The patient condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

The exact age of the patient is unknown.However, it was reported the patient was over 18 years.Problem code 1212 captures the reportable event of snare loop embedded in patient's tissue.Patient code 3191 (no code available) has been used to capture the report of patient undergoing medical intervention to remove the target polyp and the embedded snare loop.Investigation results: visual analysis of the returned device revealed that the working length was bent in several locations and the loop was also bent.It is most likely that procedural or anatomical factors encountered during the procedure could have affected the device performance and its integrity.Handling and manipulation of the device during its use can lead to bend the working length.In addition, the event description states that, "the snare sticked on the polyp;" attempts to cut the polyp or force applied to the device in order to retrieve it, can lead to bend the loop.During functional inspection, the loop was able to extend/retract without any issue when the handle was actuated.In addition, the device was submitted to an electrical test and the electrical resistance was measured to be within specification (11.7 ohms).The reported failure "loop entrapment of device or device component" cannot be confirmed since this issue could not be replicated and verified under anatomical conditions.Since the reported issues could not be confirmed, the investigation conclusion code for the reported complaint will be documented as "no problem detected" since the reported device complaint or problem cannot be confirmed.A review of the device history record (dhr) was performed and confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.

• Brand Name: CAPTIVATOR II
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8400333
• MDR Text Key: 138126408
• Report Number: 3005099803-2019-00797
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729645801
• UDI-Public: 08714729645801
• Combination Product (y/n): N
• PMA/PMN Number: K131700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/10/2020
• Device Model Number: M00561291
• Device Catalogue Number: 6129
• Device Lot Number: 20999609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2019
• Initial Date Manufacturer Received: 02/13/2019
• Initial Date FDA Received: 03/07/2019
• Supplement Dates Manufacturer Received: 03/07/2019
• Supplement Dates FDA Received: 03/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention