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

Model Number M00562401

Device Problems Failure to Deliver Energy (1211); Entrapment of Device (1212); Failure to Cut (2587); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 10/26/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to boston scientific corporation that a captivator small oval stiff snare was used during a colonoscopy procedure performed on (b)(6) 2022.During the procedure, the snare loop was around a portion of the polyp and tightened but would not cauterize and pull through the polyp.There was no evidence of cauterization or smoke.The erbe and active cord were changed out but these changes made no difference.The snare was cut at the handle and the scope was removed from the patient to pull the snare out of the channel.The scope was advanced into the colon to the point of the polyp.Biopsy forceps were then used to remove the snare from the polyp and the snare was withdrawn.The procedure was completed with a different snare.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: imdrf device code a090402 captures the reportable event of snare unable to deliver energy.Imdrf device code a050702 captures the reportable event of snare loop cutting problems.Imdrf device code a150208 captures the reportable event of loop entrapment and the required intervention.Block h10: (product investigation) one captiflex snare was received for analysis.Visual analysis of the device noted that the working length was bent, the loop was bent, and the working length and wire were detached.Microscope inspection of the working length and wire was performed and found that there was a mechanical cut at the proximal section of the strain relief.No other problems with the device were noted.The reported events of loop unable to cut and loop entrapment of device or device component could not be confirmed since they are related to the procedure and the device cannot be functionally evaluated with respect to anatomical/procedural factors encountered during the procedure.It is possible that procedural factors could make it difficult to remove the loop from the polyp, however this could not be confirmed.The reported event of device unable to deliver energy could not be confirmed due to the condition the device was returned.Functional testing could not be performed as the working length and wire were detached.The working length and loop were found bent during device analysis and the working length and wire were detached.Microscope inspection of the working length and wire found there was a mechanical cut at the proximal section of the strain relief.This matches that the customer reported that the snare was cut at the handle and the scope was removed from the patient to remove the snare.It is likely that the manner the device was handled and manipulated during the withdrawal may have caused working length and loop to be bent.Forcing the device against significant resistance could result in device damage.Based on the information available and the analysis of the returned device, the most probable root cause is adverse event related to the procedure.Block h11: block h10 has been corrected.

Event Description

It was reported to boston scientific corporation that a captivator small oval stiff snare was used during a colonoscopy procedure performed on (b)(6) 2022.During the procedure, the snare loop was around a portion of the polyp and tightened but would not cauterize and pull through the polyp.There was no evidence of cauterization or smoke.The erbe and active cord were changed out but these changes made no difference.The snare was cut at the handle and the scope was removed from the patient to pull the snare out of the channel.The scope was advanced into the colon to the point of the polyp.Biopsy forceps were then used to remove the snare from the polyp and the snare was withdrawn.The procedure was completed with a different snare.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: imdrf device code a090402 captures the reportable event of snare unable to deliver energy.Imdrf device code a050702 captures the reportable event of snare loop cutting problems.Imdrf device code a150208 captures the reportable event of loop entrapment and the required intervention.Block h10: (product investigation) one captiflex snare was received for analysis.Visual analysis of the device noted that the working length bent and detached, the wire was also detached, and the loop was bent.Microscope inspection of the returned device found that there is a mechanical cut at the proximal section of the strain relief.No other issues with the device were noted.The reported event of "device failure to deliver energy" could not be confirmed since no issues were noted with the electrical device testing during continuity test upon return.The reported event of "loop failure to cut " and "loop entrapment of device or device component" could not be confirmed since the devices cannot be functionally evaluated with respect to anatomical/procedural factors encountered during the procedure.The product record review confirmed that this is not a new failure type, and the risk is anticipated.There was no evidence of a manufacturing issue, design or user issue which could have caused the complaint.Device analysis found the working length bent and detached, the wire was detached, and the loop was bent and a mechanical cut at the proximal section of the strain relief was found during microscope inspection.Based on the analysis of the returned device and the information available, the code selected as the most probable cause is no problem detected.

Event Description

It was reported to boston scientific corporation that a captivator small oval stiff snare was used during a colonoscopy procedure performed on (b)(6) 2022.During the procedure, the snare loop was around a portion of the polyp and tightened but would not cauterize and pull through the polyp.There was no evidence of cauterization or smoke.The erbe and active cord were changed out but these changes made no difference.The snare was cut at the handle and the scope was removed from the patient to pull the snare out of the channel.The scope was advanced into the colon to the point of the polyp.Biopsy forceps were then used to remove the snare from the polyp and the snare was withdrawn.The procedure was completed with a different snare.There were no patient complications reported as a result of this event.

• Brand Name: CAPTIFLEX
• Type of Device: 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: 15978879
• MDR Text Key: 305489265
• Report Number: 3005099803-2022-07239
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729019411
• UDI-Public: 08714729019411
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K131700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00562401
• Device Catalogue Number: 6240
• Device Lot Number: 0028374095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention