MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SENSATION SHORT THROW; SNARE, FLEXIBLE

Model Number M00562673

Device Problems Electrical /Electronic Property Problem (1198); Entrapment of Device (1212); Failure to Cut (2587)

Patient Problem Tissue Damage (2104)

Event Date 09/02/2020

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 sensation medium oval flexible snare was used during a colonoscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the snare had issues cutting through the tissue both hot and cold.When using cold polypectomy, it would not cut cleanly through the tissue smoothly which caused chewing like feeling when trying to close the snare loop to resect the one (1) cm target polyp.There were no treatment provided for the tissue "chewing" experienced by the patient.When the device was used with cautery, it seemed that the current flow was not as smooth as usual and it made it more difficult to cut through the target polyps.Reportedly, the electrical current transmitted was noticed to be less than normal.The snare was securely attached to the active cord, and there were no visible issues noted with the cautery pins.An endostat generator was used, however, the settings of the generator was not reported.The physician troubleshoot the device by opening and closing the snare.The connection and cautery settings were also double checked.However, the issue was not resolved.The procedure was then completed with a different device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure is reported to be stable and fine.

• Brand Name: SENSATION SHORT THROW
• 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: 10586825
• MDR Text Key: 208553989
• Report Number: 3005099803-2020-04136
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729501664
• UDI-Public: 08714729501664
• 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: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2023
• Device Model Number: M00562673
• Device Catalogue Number: 6267-40
• Device Lot Number: 0025677105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2020
• 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