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

Model Number M00562401

Device Problems Break (1069); Entrapment of Device (1212); Failure to Cut (2587); Material Twisted/Bent (2981)

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001); Tissue Damage (2104); No Code Available (3191)

Event Date 09/24/2020

Event Type  Injury  

Manufacturer Narrative

Problem code 3191 no code available however relates to the reportable event of surgery.Problem code 2587 captures the reportable event of loop failure to cut.Problem code 1212 captures the reportable event of entrapment of device.Problem code 2104 captures the reportable event of tissue damage.Problem code 2001 captures the reportable event of perforation.Problem code 1888 captures the reportable event of hemorrhage.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 medwatch will be filed.

Event Description

Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2020-04816 and 3005099803-2020-04817 for the associated device information.It was reported to boston scientific corporation that two captiflex medium oval flexible snares were used during a colonoscopy with polypectomy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, a six (6) cm pedunculate polyp was partially removed with the first snare using cautery over a saline pillow in the sigmoid colon.The first snare could not cut through the entire polyp due to thickness and size of the polyp stalk.The device became embedded in the polyp tissue and could not be retrieved in a normal fashion.The scope was removed from the patient after the proximal lock of the snare was cut using wire cutter.Then the sheath of snare was removed and a second snare was used in an attempt to retrieve the embedded snare and remove the remaining polyp.After few attempts, it was decided to call off the procedure and send the patient to surgery for the removal of the remaining snare and polyp and also to repair the perforation and hemorrhage.Reportedly, both snares were bent and broken at the handle.The embedded snare was successfully removed surgically however the patient's current condition is unavailable.

Event Description

Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2020-04816 and 3005099803-2020-04817 for the associated device information.It was reported to boston scientific corporation that two captiflex medium oval flexible snares were used during a colonoscopy with polypectomy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, a six (6) cm pedunculate polyp was partially removed with the first snare using cautery over a saline pillow in the sigmoid colon.The first snare could not cut through the entire polyp since the snare wire was bent at the handle and was broken from the handle due to thickness and size or the polyp stalk.The device became embedded in the polyp tissue and could not be retrieved in a normal fashion.The scope was removed from the patient after the proximal lock of the snare using wire cutter.Then the sheath of snare was removed and a second snare was used to retrieve it and tried to remove the remaining polyp.After few attempts, it was decided to call off the procedure and send the patient to suregery for the removal of the remaining snare and polyp and also to repair the perforation.The embedded snare was successfully removed surgically however the patient's current condition is unavailable.*** additional information received on october 27, 2020 *** according to the complainant, the perforation was due to the snare not cutting through the polyp and being embedded in the polyp.The wire did not break until they broke it to removed the polyp; the problem was it would not cut through the polyp.No visible fractures found at the handle.

Manufacturer Narrative

Block h6: problem code 3191 no code available however relates to the reportable event of surgery.Problem code 2587 captures the reportable event of loop failure to cut.Problem code 1212 captures the reportable event of entrapment of device.Problem code 2104 captures the reportable event of tissue damage.Problem code 2001 captures the reportable event of perforation.Problem code 1888 captures the reportable event of hemorrhage.Block h10: (product investigation) a captiflex snare was received for analysis.Visual inspection of the returned device revealed that the device has the catheter detached (cut at the proximal section).In addition, the wire has evidence of mechanical cut and the distal section was not returned for analysis.The sheath was found damaged and torn.A kinked section in the proximal section was noted and the sheath was detached from handle.However, the flare was observed in a good shape.The handle section did not present any visual damage or anomalies.Functional evaluation cannot be performed due the device condition.The reported complaint for handle break was not confirmed.The reported complaint for wire bent was confirmed since the wire was bent where the sheath kinked section was noted.Additionally, the issues of loop failure to cut and loop entrapment of device or device component were confirmed according to the reported issue by the costumer and the eventual cutting of the device.The handle section did not present any visual damage or anomalies.Based on the above information, the issue occurred during procedure, based on this, it is possible that procedure practices such as user technique, handling or anatomical conditions had contributed to generate the damages found in the device.The kink observed in the proximal section may cause difficult actuating and eventually the force applied to the handle to extend the loop, could push out the flare from the handle, generating the detachment of the working length.Additionally, the flare section was observed in good conditions and during the manufacturing process the units were inspected as per catheter assembly and flaring procedure which confirms that the devices were sent in good conditions to the customer.Therefore, the most probable cause for this complaint is adverse event related to procedure, the adverse event occurred during the procedure and the device had no influence on event.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.Block h11: block b5 has been updated with the additional information received on october 27, 2020.Blocks h6 and h10 have been updated based on the investigation closure.

• Brand Name: CAPTIFLEX
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10717898
• MDR Text Key: 212512431
• Report Number: 3005099803-2020-04817
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729019411
• UDI-Public: 08714729019411
• 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: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/03/2022
• Device Model Number: M00562401
• Device Catalogue Number: 6240
• Device Lot Number: 0024873082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Date Manufacturer Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention