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); Retraction Problem (1536); Material Deformation (2976); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/28/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a captivator extra large round stiff snare was used during a colonoscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, a 33mm captivator snare was inserted to remove a large cecal polyp.The physician was able to place the initial snare around the polyp and was in the process of trying to position the snare when it was noted that there was difficulty in closing the snare.When the snare finally did close, they were unable to use the cautery feature.Several attempts were made to manipulate the snare, all of which failed.It was this time the technician involved in the case noted that the sheath surrounding the snare had a slit located about 10cm from the handle and in order for the snare to close, the technician had to manipulate the wire with her finger to get it to close.At this time, both a surgeon and the medical director of the gi lab were notified and called into the room to obtain their opinions on how to proceed.It was finally decided that the snare wire itself was needed to be cut and then both the colon scope and the sheath would need to be removed leaving the snare wire in the patient.After both the scope and wire were removed, the scope was again inserted carefully trying not to drag the wire in with it.A pair of hemostats was attached to the end of the wire to prevent any issues.Once the scope was in proper position, a second 33mm captivator snare was inserted successfully and the polyp was removed in small pieces until the original snare wire was freed and then removed from the patient.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be fine.

Manufacturer Narrative

Block h6: problem code 1212 captures the reportable event of snare loop entrapment of device or device component.Block h10: a captivator snare was received for analysis.Visual evaluation of the returned device revealed that the device has the sheath and wire cut next to the strain relief.In addition, the sheath and wire were kinked next to cut sections.The loop was visually inspected and no issues were noted.Functional evaluation of the returned device found that the device was unable to be functionally tested due to the device condition.Also, due to the catheter condition the loop was unable to extend and the continuity test was unable to be performed, consequently, the complaint related to failure to delivery energy was not confirmed.Photos were attached to the complaint record and it was possible to observe the sheath and wire severely kinked.In addition, the sheath looked torn.A risk review of the captivator snares was completed using polypectomy snares risk mgmt workbook, bsc, bu and confirmed that the events of snare damaged, unable to transmit electrical current to the device, unable or difficult to pass through scope, sheath kink and cable breaks/frays were defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Per complaint information, the problem was noticed during procedure and the device was tested before use, this is evidence that it was without issues before used.It is possible that handling factors, such as user technique/handling during procedure, contributed to the observed failures of sheath torn and kinked wire since the working length was damage at proximal section and this condition affects the proper device function.Boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications, however there is no control how the devices are handled/manipulated in the field.The devices were inspected during manufacturing process per procedure to check the opening and closing at least two times.Additionally, according to the event summary the device was cut due to the difficulties found during use and due to the device condition.Based on these facts, the most probable cause for this complaint 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.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.

Event Description

It was reported to boston scientific corporation that a captivator extra large round stiff snare was used during a colonoscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, a 33mm captivator snare was inserted to remove a large cecal polyp.The physician was able to place the initial snare around the polyp and was in the process of trying to position the snare when it was noted that there was difficulty in closing the snare.When the snare finally did close, they were unable to use the cautery feature.Several attempts were made to manipulate the snare, all of which failed.It was this time the technician involved in the case noted that the sheath surrounding the snare had a slit located about 10cm from the handle and in order for the snare to close, the technician had to manipulate the wire with her finger to get it to close.At this time, both a surgeon and the medical director of the gi lab were notified and called into the room to obtain their opinions on how to proceed.It was finally decided that the snare wire itself was needed to be cut and then both the colon scope and the sheath would need to be removed leaving the snare wire in the patient.After both the scope and wire were removed, the scope was again inserted carefully trying not to drag the wire in with it.A pair of hemostats was attached to the end of the wire to prevent any issues.Once the scope was in proper position, a second 33mm captivator snare was inserted successfully and the polyp was removed in small pieces until the original snare wire was freed and then removed from the patient.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be fine.

• 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: 9727048
• MDR Text Key: 188651626
• Report Number: 3005099803-2020-00495
• 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,health
• Type of Report: Initial,Followup
• Report Date: 04/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/26/2021
• Device Model Number: M00561291
• Device Catalogue Number: 6129
• Device Lot Number: 0021798806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Date Manufacturer Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention