MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTATABLE SNARE; SNARE, FLEXIBLE

Model Number M00561831

Device Problems Electrical /Electronic Property Problem (1198); Failure to Deliver Energy (1211); Failure to Cut (2587)

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

Event Date 01/01/2023

Event Type  malfunction  

Manufacturer Narrative

Event date: approximated based on the date the manufacturer became aware of the event.Imdrf device code a090402 captures the reportable event of suboptimal cautery.Imdrf device code a050702 captures the reportable event of unable to cut.

Event Description

It was reported to boston scientific corporation that a rotatable medium oval med stiff snare was used during a polypectomy procedure performed on an unknown date.During the procedure, the energization time was longer, and the sharpness was poor.The procedure was completed with this device.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a07 captures the reportable event of suboptimal cautery.Imdrf device code a050702 captures the reportable event of unable to cut.Block h10: block h6 device code has been corrected.

Event Description

It was reported to boston scientific corporation that a rotatable medium oval med stiff snare was used during a polypectomy procedure performed on an unknown date.During the procedure, the energization time was longer and the sharpness was poor.The procedure was completed with this device.There were no patient complications reported as a result of this event.

• Brand Name: ROTATABLE SNARE
• 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: 16372877
• MDR Text Key: 309504116
• Report Number: 3005099803-2023-00416
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729283997
• UDI-Public: 08714729283997
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160637
• 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
• Report Date: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00561831
• Device Catalogue Number: 6183
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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