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

Model Number M00562402

Device Problems Failure to Cut (2587); Defective Device (2588); Human-Device Interface Problem (2949)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/21/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a captiflex medium oval flexible snare was used during a colonoscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure and inside the patient, the physician stated that there appeared to be a decrease of heat and significantly decrease cutting ability, potentially resulting for a unnecessary thermal injury.Reportedly, the snare was securely attached to the active cord and there were no visible issues noted with the cautery pin.The technician stated that there was decreased tactile feel and that the new labels on the handle of the snare (instead of the color-coated handles) confused them and caused them to open incorrect packages.The procedure was completed with this device.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: 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: 10153833
• MDR Text Key: 195124573
• Report Number: 3005099803-2020-02298
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729501640
• UDI-Public: 08714729501640
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2023
• Device Model Number: M00562402
• Device Catalogue Number: 6240-40
• Device Lot Number: 0025111007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2020
• 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