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

Model Number M00560311

Device Problems Failure to Cut (2587); Defective Device (2588)

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

Event Date 08/01/2023

Event Type  malfunction  

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a050702 captures the reportable event of snare loop cutting problems.

Event Description

It was reported to boston scientific corporation that a sensation medium oval med stiff snare was used during a colonoscopy with polypectomy procedure performed on an unknown date.During the procedure, the snare was not able to cut the polyps.The procedure was completed.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that a sensation medium oval med stiff snare was used during a colonoscopy with polypectomy procedure performed on an unknown date.During the procedure, the snare was not able to cut the polyps.It was not reported what device was used to complete the procedure.There were no patient complications reported as a result of this event.According to additional information received on september 20, 2023, the sheaths on the snares that worked were longer, while the shorter sheaths were indicative of device malfunction.The exact number of device that were unable to cut is unknown however it has the reported upn & lot of upn - m00560310.Lot #31773344.The complaint was reported late since it came to the sales representative's attention after completed the training and the procedure was completed with the a similar sensation medium oval med stiff snare.

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a050702 captures the reportable event of unable to cut.Block h11: block b5 has been updated based on additional information received on september 20, 2023.

• 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: 17774768
• MDR Text Key: 323746690
• Report Number: 3005099803-2023-04909
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729283904
• UDI-Public: 08714729283904
• 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
• Report Date: 10/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00560311
• Device Catalogue Number: 6031
• Device Lot Number: 0031773344
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2023
• 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