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

Model Number M00562652

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

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

Event Date 01/31/2023

Event Type  Injury  

Manufacturer Narrative

Initial reporter: the reported healthcare facility is: (b)(6) hospital, united states, (b)(6).Imdrf impact code f23 captures the reportable event of unexpected medical intervention.Imdrf device code a150208 captures the reportable event of loop entrapment of device.Imdrf device code a050702 captures the reportable event of polyp cutting issue.

Event Description

It was reported to boston scientific corporation that a sensation large oval med stiff snare was used during a polypectomy procedure performed on (b)(6) 2023.During the procedure, the snare would not cut the tissue and the snare was cut out of the scope.The procedure was completed with an unknown device.There were no patient complications reported as a result of this event.

• 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: 16459682
• MDR Text Key: 310421950
• Report Number: 3005099803-2023-00758
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729268802
• UDI-Public: 08714729268802
• 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: Other
• Type of Report: Initial
• Report Date: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00562652
• Device Catalogue Number: 6265-20
• Device Lot Number: 0030439644
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2022
• 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