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

Model Number M00561830

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 09/13/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

Event Description

It was reported to boston scientific corporation that a rotatable medium oval med stiff snare was used in the transverse colon during a polypectomy procedure performed on (b)(6) 2022.During preparation, system connection was not possible.There was no connector on the snare, and it was impossible to connect the handle of the snare to the erbe system.The procedure was completed with another rotatable snare.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: 15607751
• MDR Text Key: 306913488
• Report Number: 3005099803-2022-05956
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729747710
• UDI-Public: 08714729747710
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K992477
• 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
• Report Date: 10/14/2022

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 Model Number: M00561830
• Device Catalogue Number: 6183S
• Device Lot Number: 0029050166
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2022
• Initial Date FDA Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2022
• 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