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); Activation, Positioning or Separation Problem (2906)

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

Event Date 03/30/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a15 captures the reportable event of sheath could not detach as normal.

Event Description

It was reported to boston scientific corporation that a resolution 360 clip device was used in the colon during an endoscopic mucosal resection (emr) performed on (b)(6) 2023.During the procedure, the external sheath could not detach as normal.The procedure was completed with another resolution 360 clip device.The procedure was completed with another resolution 360 clip device.The patient condition at the conclusion of the procedure was reported to be stable.No further information has been obtained despite good faith efforts.

Manufacturer Narrative

Block h2: additional information: block b5 (describe event or problem) and block h6 (device code) have been updated based on the additional information received on april 24, 2023.Block h6 has been updated to code for premature deployment in the colon, deeming this a non-reportable scenario.

Event Description

It was reported to boston scientific corporation that a resolution 360 clip device was used in the colon during an endoscopic mucosal resection (emr) performed on (b)(6) 2023.During the procedure, the external sheath could not detach as normal.The procedure was completed with another resolution 360 clip device.The procedure was completed with another resolution 360 clip device.The patient condition at the conclusion of the procedure was reported to be stable.Additional information received on april 24, 2023 it was reported that when the outer sheath tube of the clip disengages the clip fell off.

• 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: 16814689
• MDR Text Key: 314000051
• Report Number: 3005099803-2023-02107
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 08714729875642
• UDI-Public: 08714729875642
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/09/2023
• Device Model Number: M00521232
• Device Catalogue Number: 54774
• Device Lot Number: 0026418721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/24/2020
• 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 Age: 67 YR
• Patient Sex: Male
• Patient Weight: 65 KG