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

Model Number	M00562673
Medical Device Problem Codes	Entrapment of Device (1212); Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2023
Type of Reportable Event	Serious Injury
Event or Problem 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) 2023.During the procedure, three different physicians from three separate procedures were attempting to remove a large polyp with a snare, but encountered difficulties.The snare became stuck while trying to cut through the polyp, making it impossible to cauterize it.Despite their efforts, they were unable to remove the snare and had to resort to cutting off the plastic sheath using pliers and then utilized a 15mm captivator ii snare to remove the remaining parts of the polyp in small pieces, dislodging the original snare.This occurred with two separate batches of the same snare.The procedure was completed with a captivator ii snare.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block d4, h4: the suspect device upn and lot number do not populate; therefore, the manufacture and expiration dates are unknown.Block h6: imdrf device code a150208 captures the reportable event of loop entanglement within the patient's tissue.Imdrf device code a050702 captures the reportable event of loop cutting issue.
Additional Manufacturer Narrative
Block d4, h4: the suspect device lot number is not reported; therefore, the manufacture and expiration dates are unknown.Block h6: imdrf device code a150208 captures the reportable event of loop entanglement within the patient's tissue.Imdrf device code a050702 captures the reportable event of unable to cut.
Event or Problem 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) 2023.During the procedure, three different physicians from three separate procedures were attempting to remove a large polyp with a snare, but encountered difficulties.The snare became stuck while trying to cut through the polyp, making it impossible to cauterize it.Despite their efforts, they were unable to remove the snare and had to resort to cutting off the plastic sheath using pliers and then utilized a 15mm captivator ii snare to remove the remaining parts of the polyp in small pieces, dislodging the original snare.This occurred with two separate batches of the same snare.The procedure was completed with a captivator ii snare.There were no patient complications reported as a result of this event.

• Brand Name: SENSATION SHORT THROW
• Common Device Name: 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: 17577517
• Report Number: 3005099803-2023-04225
• Device Sequence Number: 8877188
• Product Code: FDI
• UDI-Device Identifier: 08714729501664
• UDI-Public: 08714729501664
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K131700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00562673
• Device Catalogue Number: 6267-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/30/2023
• Supplement Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 08/18/2023
• Supplement Report FDA Received Date: 09/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown