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

Model Number M00562422

Device Problems Entrapment of Device (1212); Mechanical Problem (1384); Failure to Cut (2587)

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

Event Date 06/04/2021

Event Type  malfunction  

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 captiflex small oval flexible snare was to be used during a colonoscopy procedure performed on (b)(6) 2021.It was reported that during the procedure, the snare was stuck to the actual tissue.It would not cut hot or cold and they couldn't open it because the tissue was stuck.The tech and physician kept jiggling the snare but it would not cut through.Reportedly, there were no issues noted upon opening the package.The snare was securely attached to the active cord and there were no visible issues noted with the cautery pins.The procedure was completed with a completely different snare.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

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.Conclusion code d17 is being used in lieu of an adequate conclusion code for "device not returned." block h10: 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.Block h11: blocks b5, e1 (initial reporter last name and initial reporter email), and h6 have been updated based on the additional information received on (b)(6), 2021 and investigation closure for no device returned.

Event Description

It was reported to boston scientific corporation that a captiflex small oval flexible snare was to be used during a colonoscopy procedure performed on (b)(6) 2021.It was reported that during the procedure, the snare was stuck to the actual tissue.It would not cut hot or cold and they couldn't open it because the tissue was stuck.The tech and physician kept jiggling the snare but it would not cut through.Reportedly, there were no issues noted upon opening the package.The snare was securely attached to the active cord and there were no visible issues noted with the cautery pins.The procedure was completed with a completely different snare.There were no patient complications reported as a result of this event.***additional information received on (b)(6), 2021*** no visible issue was noted with the handle and the device.The patient condition following the procedure was reported to be stable.

Event Description

It was reported to boston scientific corporation that a captiflex small oval flexible snare was to be used during a colonoscopy procedure performed on (b)(6) 2021.It was reported that during the procedure, the snare was stuck to the actual tissue.It would not cut hot or cold and they couldn't open it because the tissue was stuck.The tech and physician kept jiggling the snare but it would not cut through.Reportedly, there were no issues noted upon opening the package.The snare was securely attached to the active cord and there were no visible issues noted with the cautery pins.The procedure was completed with a completely different snare.There were no patient complications reported as a result of this event.***additional information received on (b)(6), 2021*** no visible issue was noted with the handle and the device.The patient condition following the procedure was reported to be stable.

Manufacturer Narrative

Block h6: problem code a050702 captures the reportable event of snare loop cutting problem.Problem code a150208 captures the reportable event of snare loop entrapment.Block h10: investigation results a captiflex small oval flexible snare was received for analysis.Visual inspection of the returned device revealed that the sheath was separated from the device and had evidence of flaring, and the wire was kinked.Functional test was not performed due to the device condition.Electrical test was performed and the device passed, indicating a proper connection.No other problems were noted.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 reported event of loop entrapment of device or device component was unable to be confirmed since the device cannot be functionally evaluated.However, the device was carefully inspected and the sheath was separated from the device (flare detached) with evidence of flaring.This flare detached could induce an extension problem, therefore confirming the reported event of loop failure to extend.Upon product analysis, it was observed that the entrapment of the device or device component could not be functionally confirmed, however, it is probable that during the use of the loop due to the size of the tissue or any other circumstance of the anatomy, the loop stuck and the snare was jiggled which caused the wire to kink and the sheath to separate from the device (flare detached), causing an extension problem.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is adverse event related to procedure.This is defined as 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.

• 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: 12107287
• MDR Text Key: 259651240
• Report Number: 3005099803-2021-03055
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729501657
• UDI-Public: 08714729501657
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 02/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2024
• Device Model Number: M00562422
• Device Catalogue Number: 6242-40
• Device Lot Number: 0026840563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2021
• 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