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

Model Number	M00561242
Medical Device Problem Codes	Failure to Deliver Energy (1211); Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 or Problem Description
It was reported to boston scientific corporation that a captivator ii-20mm round stiff snare was used in the rectum during a polypectomy procedure performed on (b)(6) 2021.It was reported that during the procedure and inside the patient, the esu did not activate.The procedure was completed with another captivator snare.A follow up procedure was scheduled due to the polypectomy being completed by piecemeal resection versus removal from hot snare.It was reported that the return visit most likely will be for a flexible sigmoidoscopy for surveillance of the polypectomy site in the rectum.
Additional Manufacturer Narrative
Block h6: problem code a050702 the reportable event of snare loop cutting problems.Impact code f2202 captures the reportable event of additional endoscopic procedure.Block h10: investigation results a captivator ii-20mm round stiff snare was received for analysis.Visual and microscope inspection of the returned device revealed that the 2 in 1 active cord connector did not have any visual problems.The working length (catheter) was kinked approximately at 52cm and 54cm from distal section of the handle, and also was bent at the distal section.The thumb ring at the main handle and the finger ring were damaged (deformed).Also, the snare loop was bent.Functional inspection was performed and device was manually actuated and the loop was able to extend and retract.Electrical test was performed and the device was found within manufacturing specifications.No other problems were noted.Visual assessment of the device noted that the working length (catheter) was kinked/bent in some locations including the distal section, the distal section of the working length (tip section) was damaged (deformed), the thumb ring at the main handle and the finger ring were damaged (deformed), and the loop was bent.These problems occurred during the procedure and it was most likely that handling and manipulation of the device during its use could have affected the device performance and its integrity.Interaction with the scope during device advancement can lead to kinking/bending of the device.Even though the electrical test and functional inspection were found within specifications, difficulty to cut cutting the tissue can cause the loop to bend.This condition can cause the tissue caught in the loop and force applied to cut the tissue can damage the tip of the working length and the thumb ring/finger ring.Settings of the generator and the condition of the active cord connected to the device and generator can cause problems to deliver energy and consequently difficulties in dissecting the tissue causing the observed damages on the device.The observed problems have been assigned the cause code of "adverse event related to procedure" since the adverse event occurred during the procedure and the device had no influence on the event.The reported complaint of loop failure to cut could not be confirmed since the device cannot be functionally evaluated with respect to anatomical/procedural factors encountered during the procedure.The reported event of "device failure to deliver energy" was not confirmed since the device passed the electrical test upon return.After analysis it was determined that the 2 in 1 active cord connector did not have any visual problems, the device passed electrical testing and during functional inspection it worked as intended; the unit returned did not show evidence of either the alleged problems or any defect which could have contributed to the event, therefore, it was concluded that the investigation conclusion code for the complaint is "no problem detected" since the reported event cannot be confirmed.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
Event or Problem Description
It was reported to boston scientific corporation that a captivator ii-20mm round stiff snare was used in the rectum during a polypectomy procedure performed on (b)(6) 2021.It was reported that during the procedure and inside the patient, the esu did not activate.The procedure was completed with another captivator snare.A follow up procedure was scheduled due to the polypectomy being completed by piecemeal resection versus removal from hot snare.It was reported that the return visit most likely will be for a flexible sigmoidoscopy for surveillance of the polypectomy site in the rectum.

• Brand Name: CAPTIVATOR II
• Common Device Name: 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: 12669005
• Report Number: 3005099803-2021-05447
• Device Sequence Number: 17183897
• Product Code: FDI
• UDI-Device Identifier: 08714729861362
• UDI-Public: 08714729861362
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K133987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/05/2024
• Device Model Number: M00561242
• Device Catalogue Number: 50296
• Device Lot Number: 0026925019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/23/2021
• Supplement Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 10/20/2021
• Supplement Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 75 KG