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

Model Number M00562671

Device Problem Failure to Cut (2587)

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

Event Date 12/07/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

Note: this report pertains to the first of three devices used during the same procedure.It was reported to boston scientific corporation that a sensation medium oval flexible snare was used during a colonoscopy procedure performed on (b)(6) 2021.During the procedure,the snare would not cut through the polyp.Two more sensation short throw snares were tried and would not cut through the polyp.The procedure was completed using an additional sensation short throw.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: problem code a050702 captures the reportable event of loop unable to cut.Block h10: investigation results a sensation medium oval flexible snare was received for analysis.Visual inspection of the returned device revealed that no problems had been found.Functional inspection was performed and device contracted and extended well.Electrical test was performed and the device passed, indicating a proper connection.No other problems were noted.The reported complaint of loop failure to cut could not be confirmed since the device cannot be functionally evaluated with respect to anatomical/procedural factors encountered during the procedure.The product record review confirmed that this was not a new failure type and the risk was anticipated.There was no evidence of a manufacturing problem, design or user problem which could have caused the complaint.Device analysis found no problems with the device during visual and functional tests.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is no problem detected.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

Event Description

Note: this report pertains to the first of three devices used during the same procedure.It was reported to boston scientific corporation that a sensation medium oval flexible snare was used during a colonoscopy procedure performed on (b)(6) 2021.During the procedure, the snare would not cut through the polyp.Two more sensation short throw snares were tried and would not cut through the polyp.The procedure was completed using an additional 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: 13122203
• MDR Text Key: 283242969
• Report Number: 3005099803-2021-08074
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729158141
• UDI-Public: 08714729158141
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00562671
• Device Catalogue Number: 6267
• Device Lot Number: 0027746727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2021
• 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