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

Model Number M00521232

Device Problems Premature Activation (1484); Use of Device Problem (1670)

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

Event Date 03/07/2023

Event Type  malfunction  

Manufacturer Narrative

Block a2: patient's exact age is unknown; however, it was reported that the patient is at her 60s.Block h6: imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.

Event Description

Note: this report pertains to one of three resolution 360 clips used in the same patient and procedure.It was reported to boston scientific corporation that three resolution 360 clip devices were used in the duodenum during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, the clip was passed down the duodenoscope; however, the clip deployed at the elevator of the scope.The same problem occurred with the second and third resolution 360 clips.The procedure was not completed due to the device was unable to clip the diverticulum in order to access the ampulla.Note: it was reported that the scope used was a duodenoscope.However, per the instructions for use (ifu), hemostasis clip is designed to be compatible with forward viewing endoscopes only.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block a2: patient's exact age is unknown; however, it was reported that the patient is at her 60s.Block h2: additional information: block b5 (describe event or problem) block h6: imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.

Event Description

Note: this report pertains to one of three resolution 360 clips used in the same patient and procedure.It was reported to boston scientific corporation that three resolution 360 clip devices were used in the duodenum during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, the clip was passed down the duodenoscope; however, the clip deployed at the elevator of the scope.The same problem occurred with the second and third resolution 360 clips.The procedure was not completed due to the device was unable to clip the diverticulum in order to access the ampulla.Note: it was reported that the scope used was a duodenoscope.However, per the instructions for use (ifu), hemostasis clip is designed to be compatible with forward viewing endoscopes only.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.***additional information received on april 6, 2023*** it was reported that the procedure was performed on (b)(6) 2023.

• 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: 16673446
• MDR Text Key: 313418908
• Report Number: 3005099803-2023-01636
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 08714729875642
• UDI-Public: 08714729875642
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 04/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• 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: 0030577384
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2022
• 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 Sex: Female