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

Model Number M00521401

Device Problem Defective Device (2588)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/10/2023

Event Type  Injury  

Manufacturer Narrative

This event was reported by the sales representative.The health care facility is: (b)(6).Imdrf device code a0203 captures the reportable event of clip falling off tissue after placement.Imdrf patient code e0506 captures the reportable event of patient hemorrhage.Imdrf impact code f23 captures the reportable event of unexpected medical intervention.

Event Description

It was reported to boston scientific corporation that a resolution 360 clip device was placed in the colon during a procedure performed on (b)(6) 2023.On (b)(6) 2023 the patient was re-admitted for bleeding.The physician re-scoped the patient, and noticed that the clip was no longer attached to the tissue which caused bleeding to the patient.The procedure was completed with another resolution 360 ultra clips.The patient had fully recovered.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that a resolution 360 ultra clip device was placed in the colon during a procedure performed on (b)(6) 2023.On february 10, 2023 the patient was re-admitted for bleeding.The physician re-scoped the patient and noticed that the clip was no longer attached to the tissue which caused bleeding to the patient.The procedure was completed with another resolution 360 ultra clips.It was reported that the patient had fully recovered.

Manufacturer Narrative

Section e: this event was reported by the sales representative.The health care facility is: (b)(6).Block h6: imdrf device code a0203 captures the reportable event of clip falling off tissue post placement.Imdrf patient code e0506 captures the reportable event of patient hemorrhage.Imdrf impact code f23 captures the reportable event of unexpected medical intervention.

Manufacturer Narrative

Section e: this event was reported by the sales representative.The health care facility is: (b)(6) hospital.(b)(6).Block h2: additional information: block b5 has been updated based on the additional information received on march 20, 2023.Block h6: imdrf device code a0203 captures the reportable event of clip falling off tissue post placement.Imdrf patient code e0506 captures the reportable event of patient hemorrhage.Imdrf impact code f23 captures the reportable event of unexpected medical intervention.

Event Description

It was reported to boston scientific corporation that a resolution 360 ultra clip device was placed in the colon during a procedure performed on (b)(6) 2023.On (b)(6) 2023, the patient was re-admitted for bleeding.The physician re-scoped the patient and noticed that the clip was no longer attached to the tissue which caused bleeding to the patient.The procedure was completed with another resolution 360 ultra clips.It was reported that the patient had fully recovered.Additional information received on march 20, 2023: it was clarified that a colonoscopy procedure was performed on (b)(6) 2023.The procedure was completed with another resolution 360 ultra clip and an epinephrine.

• Brand Name: RESOLUTION 360 ULTRA 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: 16544367
• MDR Text Key: 311295226
• Report Number: 3005099803-2023-01256
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 08714729997252
• UDI-Public: 08714729997252
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00521401
• Device Catalogue Number: 2140
• Device Lot Number: 0030604695
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/17/2023
• Initial Date FDA Received: 03/15/2023
• Supplement Dates Manufacturer Received: 03/15/2023; 03/20/2023
• Supplement Dates FDA Received: 03/17/2023; 04/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2022
• 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
• Patient Outcome(s): Required Intervention