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

Model Number M00562671

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

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

Event Date 03/06/2023

Event Type  malfunction  

Manufacturer Narrative

Initial reporter facility: (b)(6).Initial reporter city: (b)(6).Imdrf device code a050702 captures the reportable event of loop unable to cut.

Event Description

This report pertains to one of five sensation short throws used in the same procedure.It was reported to boston scientific corporation that a sensation medium oval flexible snare was used during an endoscopic mucosal resection procedure performed on (b)(6) 2023.During the procedure, when the handle was tightened all the way, the polyp could not be removed.It was noted that the outer sheath at the front end of the device was found to be shorter when fully withdrawn when compared to the device used to complete the procedure.The procedure was completed with a similar sensation short throw.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block e1:(b)(6) hospital.Block h6: imdrf device code a050702 captures the reportable event of loop unable to cut.Block e1 (initial reporter address 1) has been updated based on additional information received april 5, 2023.

Event Description

Note: this report pertains to one of five sensation short throws used in the same procedure.It was reported to boston scientific corporation that a sensation medium oval flexible snare was used during an endoscopic mucosal resection procedure performed on (b)(6) 2023.During the procedure, when the handle was tightened all the way, the polyp could not be removed.It was noted that the outer sheath at the front end of the device was found to be shorter when fully withdrawn when compared to the device used to complete the procedure.The procedure was completed with a similar sensation short throw.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block e1: (initial reporter facility) (b)(6) hospital.Block e1: (initial reporter city) (b)(6).Block h6: imdrf device code (b)(6) captures the reportable event of loop unable to cut.Block e1 (initial reporter address 1) has been updated based on additional information received april 5, 2023.Block h10 investigation results: one sensation snare was received for analysis.Upon visual inspection, there were no issues observed.The reported event of "loop failure to cut" could not be confirmed, as it was not possible to evaluate the device's function during the specific procedure.It is possible that procedural factors, such as physician technique or handling of the device during initial use or set-up, may have contributed to the device's condition.The product record review revealed that this was not a new failure type and the risk had been anticipated.There was no evidence of a manufacturing, design, or user problem that could have caused the complaint.Device analysis found there were no issues during visual inspection.Based on the available information and device analysis, the most probable root cause for the reported complaint is "no problem detected,".A review of the device history record (dhr) confirmed that the device met all material, assembly, and performance specifications at the time of release for distribution.

Event Description

Note: this report pertains to one of five sensation short throws used in the same procedure.It was reported to boston scientific corporation that a sensation medium oval flexible snare was used during an endoscopic mucosal resection procedure performed on (b)(6) 2023.During the procedure, when the handle was tightened all the way, the polyp could not be removed.It was noted that the outer sheath at the front end of the device was found to be shorter when fully withdrawn when compared to the device used to complete the procedure.The procedure was completed with a similar sensation short throw.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: 16645368
• MDR Text Key: 312865937
• Report Number: 3005099803-2023-01395
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729158141
• UDI-Public: 08714729158141
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K131700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: M00562671
• Device Catalogue Number: 6267
• Device Lot Number: 0027239139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2021
• 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 Age: 56 YR
• Patient Sex: Male
• Patient Weight: 74 KG