MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESOLUTION 360 CLIP; HEMOSTATIC METAL CLIP FOR THE GI TRACT

Model Number M00521230

Device Problems Human-Device Interface Problem (2949); Material Twisted/Bent (2981)

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

Event Date 02/01/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation resolution 360 clip was used during a gastroscopy procedure performed on an unknown date.During the procedure, when the clip was deployed, one side of the clip bent backwards resulting in a sharp edge being exposed.The procedure was completed with another resolution 360 clip device.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Approximated based on the date the manufacturer became aware of the event.Imdrf device code a22 captures the reportable event of traumatic edges.

• Brand Name: RESOLUTION 360 CLIP
• Type of Device: HEMOSTATIC METAL CLIP FOR THE GI TRACT
• 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: 16442800
• MDR Text Key: 310253588
• Report Number: 3005099803-2023-00943
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 08714729875628
• UDI-Public: 08714729875628
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K222503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00521230
• Device Catalogue Number: 54772
• Device Lot Number: 0029124430
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2022
• 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