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

Model Number M00562341

Device Problems Failure to Deliver Energy (1211); Entrapment of Device (1212); Failure to Cut (2587)

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

Event Date 04/01/2021

Event Type  Injury  

Manufacturer Narrative

(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

It was reported to boston scientific corporation that a captivator medium hexagonal stiff snare was to be used in the distal ascending transverse colon to remove a 30 mm polyp during a colonoscopy procedure performed on (b)(6) 2021.It was reported that during the procedure and inside the patient, when they put the 27mm captivator hexagonal stiff snare around the polyp and applied cautery, the cautery sounded but there was no evidence of cautery/cutting by the snare.The electrocautery generator used was an erbe vio 200 with a settings of monopolar, forced coag, effect 2 max watts 25.They changed the cautery units with the same outcome.When the physician attempted to resect the large polyp the snare failed to cauterize.The physician then tried to remove the snare, however, the snare loop was imbedded in the tissue and could not be removed after many attempts.The physician opted to cut snare wire in order to safely remove the scope (cf-190l) from the patient keeping the snare loop inside the patient.Afterwards, the snare cables were looped, wrapped in gauze, and taped to the patient.The patient was sedated and was then transferred from the endoscopy center to the hospital for surgery to remove the snare and polyp.The surgery was performed was accomplished laparoscopically.The patient's condition was reported to be stable.

Event Description

It was reported to boston scientific corporation that a captivator medium hexagonal stiff snare was to be used in the distal ascending transverse colon to remove a 30 mm polyp during a colonoscopy procedure performed on (b)(6) 2021.It was reported that during the procedure and inside the patient, when they put the 27mm captivator hexagonal stiff snare around the polyp and applied cautery, the cautery sounded but there was no evidence of cautery/cutting by the snare.The electrocautery generator used was an erbe vio 200 with a settings of monopolar, forced coag, effect 2 max watts 25.They changed the cautery units with the same outcome.When the physician attempted to resect the large polyp the snare failed to cauterize.The physician then tried to remove the snare, however, the snare loop was imbedded in the tissue and could not be removed after many attempts.The physician opted to cut snare wire in order to safely remove the scope (cf-190l) from the patient keeping the snare loop inside the patient.Afterwards, the snare cables were looped, wrapped in gauze, and taped to the patient.The patient was sedated and was then transferred from the endoscopy center to the hospital for surgery to remove the snare and polyp.The surgery was performed was accomplished laparoscopically.The patient's condition was reported to be stable.

Manufacturer Narrative

Block h6: problem code a050702 captures the reportable event of snare loop cutting issue.Problem code a150208 captures the reportable event of snare loop entrapment.Health impact code f19 is being utilized to capture patient undergoing surgery.Block h10: investigation results a captivator medium hexagonal stiff snare was received for analysis.Visual inspection of the returned device revealed that the working length and wire were cut off.Continuity test was performed and the device passed, indicating a proper connection.No other issues were noted.The reported events of "failure to deliver energy, loop failure to cut and loop entrapment of device or device component" were not confirmed since the device cannot be functionally evaluated with respect to anatomical/procedural factors encountered during the procedure due to the sheath and wire cut off making it impossible to perform any test.The product record review confirmed that this was not a new failure type and the risk was anticipated.There is no evidence of a manufacturing issue, design or user issue which could have caused the complaint.It was reported that the snare was embedded in the polyp and intervention was required.Upon device analysis it was noted that the working length and wire were cut off which matched with the reported complaint which stated that the device was cut.The user may have applied excessive force trying to remove the device from the polyp resulting in the device damaged.There was no evidence of a manufacturing issue, design or user issue which could have caused the complaint.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is no problem detected.This code was selected as the problem cannot be confirmed based on device condition that made it impossible to perform any tests.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

• Brand Name: CAPTIVATOR
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11724445
• MDR Text Key: 247269491
• Report Number: 3005099803-2021-01859
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729019350
• UDI-Public: 08714729019350
• 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: 08/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/09/2023
• Device Model Number: M00562341
• Device Catalogue Number: 6234
• Device Lot Number: 0026153134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2021
• Date Manufacturer Received: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR