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

Model Number M00561231

Device Problems Electrical /Electronic Property Problem (1198); Failure to Cut (2587)

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

Event Date 06/11/2021

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to provide the lot number of the suspect device.Therefore, the manufacture and expiration dates are unknown.(b)(4).The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

Note: this report pertains to one of four devices used during the same procedure.Refer to manufacturer report # 3005099803-2021-03236, 3005099803-2021-03238 and 3005099803-2021-03239 for the associated device information.It was reported to boston scientific corporation that a captivator ii-15mm round stiff snare was to be used in the colon to remove a mass during a colonoscopy procedure performed on (b)(6) 2021.It was reported that during the procedure and inside the patient, physician attempted to resect a lesion first using a captivator ii 15mm (m00561230), a second captivator ii 15mm (m00561230), then a captivator ii 25mm (m00561190), and lastly a captivator crescent 27mm (m00562370).The lesion was noted to be fibrotic.None of the snares would cut efficiently and seemed to only "heat up" at the tip of the snare.The physician could blanch the tissue using the tip, but when the snare was opened around the lesion, it did not seem to have any cutting power in the loop of the snare.The nurse/techs tried multiple snares, changed out the ground pads, active cords, and generators.Additionally, the snare was securely attached to the active and no issues were noted in the cautery pin but nothing resolved the problem.The physician decided to stop the case and bring the patient back at a later time.The procedure was cancelled and physician is not planning on completing the procedure.The patient was sedated when the procedure was cancelled.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be fine.

Manufacturer Narrative

Block d4, h4: the complainant was unable to provide the lot number of the suspect device.Therefore, the manufacture and expiration dates are unknown.Block h6: problem code a07 captures the reportable device delivers energy intermittently.Problem code a050702 captures the reportable event of snare loop cutting issues.Block h10: investigation results a captivator ii-15mm round stiff snare was received for analysis.Visual inspection of the returned device revealed no problems were noted.Continuity test was performed and the device passed, indicating a proper connection.During functional inspection, device was connected to the 10 inch loop fixture and the loop extended and contracted without issues.No other problems were noted.The reported event of "device delivers energy intermittently" was not confirmed since the device passed the continuity test upon return.The reported event 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 product record review confirmed that this was not a new failure type and the risk was anticipated.There was no evidence of a manufacturing issue, design or user issue which could have caused the complaint.Device analysis found no problems with the device during visual test.No problems were noted with the electrical device testing during continuity test.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is no problem detected.A review of the manufacturing documentation for this device was unable to be performed as the lot number is unknown.

Event Description

Note: this report pertains to one of four devices used during the same procedure.Refer to manufacturer report # 3005099803-2021-03236, 3005099803-2021-03237, 3005099803-2021-03238 and 3005099803-2021-03239 for the associated device information.It was reported to boston scientific corporation that a captivator ii-15mm round stiff snare was to be used in the colon to remove a mass during a colonoscopy procedure performed on (b)(6), 2021.It was reported that during the procedure and inside the patient, physician attempted to resect a lesion first using a captivator ii 15mm (m00561230), a second captivator ii 15mm (m00561230), then a captivator ii 25mm (m00561190), and lastly a captivator crescent 27mm (m00562370).The lesion was noted to be fibrotic.None of the snares would cut efficiently and seemed to only "heat up" at the tip of the snare.The physician could blanch the tissue using the tip, but when the snare was opened around the lesion, it did not seem to have any cutting power in the loop of the snare.The nurse/techs tried multiple snares, changed out the ground pads, active cords, and generators.Additionally, the snare was securely attached to the active and no issues were noted in the cautery pin but nothing resolved the problem.The physician decided to stop the case and bring the patient back at a later time.The procedure was cancelled and physician is not planning on completing the procedure.The patient was sedated when the procedure was cancelled.There were no patient complications reported as a result of this event.The patient condition following 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: 12120835
• MDR Text Key: 261458765
• Report Number: 3005099803-2021-03237
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729855910
• UDI-Public: 08714729855910
• Combination Product (y/n): N
• PMA/PMN Number: K133987
• 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: 09/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00561231
• Device Catalogue Number: 6123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• Date Manufacturer Received: 08/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1