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

Model Number M00562671

Device Problems Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)

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

Event Date 12/18/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(product investigation): one sensation snare was received for analysis.Visual inspection of the returned device revealed that the loop was broken and with evidence of blackened wire which was burned.It was reported that the snare was bent outside the patient.However, upon device analysis it was noted that the loop was broken and with evidence of blackened wire (burned).This failure may occur due to an excessive application of power during the cauterization process, which causes an overheating of the wire and finally it breaks.There is no evidence of a manufacturing issue, design or user issue which could have caused the complaint.Therefore, taking into consideration the evaluation conducted at the complaint investigation site and the details of the complaint, this investigation is assigned the most probable conclusion code of adverse event related to procedure.This is defined as a complaint were an adverse event occurred during the procedure and the device had no influence on the event.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.

Event Description

It was reported to boston scientific corporation that a sensation medium oval flexible snare was to be used during a polyps treatment procedure performed on (b)(6) 2020.It was reported that during preparation and outside the patient, it was found out prior to patient sedation that the snare loop was deformed and it was not round.Reportedly, the snare loop was noted to be bent.The procedure was completed with another sensation snare.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Note: this event has been deemed an mdr-reportable event based on the investigation results which revealed that the snare loop was broken and with evidence of blackened wire (burned).

• 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: 11454798
• MDR Text Key: 242039700
• Report Number: 3005099803-2021-00776
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/26/2021
• Device Model Number: M00562671
• Device Catalogue Number: 6267
• Device Lot Number: 0022569671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2021
• Initial Date FDA Received: 03/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2018
• 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: 65 YR
• Patient Weight: 80