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

Model Number M00521232

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 01/18/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a resolution 360 clip device was used during a procedure performed on (b)(6) 2023.During the procedure, the clip would not come off the catheter and tore the tissue.The procedure was completed with another resolution 360 clip.It was reported that the scope appeared torqued.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Imdrf device code a15 captures the reportable event of clip would not come off the catheter.

• 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: 16428856
• MDR Text Key: 310079904
• Report Number: 3005099803-2023-00906
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 08714729875642
• UDI-Public: 08714729875642
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K222503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00521232
• Device Catalogue Number: 54774
• Device Lot Number: 0030316647
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2022
• 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