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

Model Number M00521232

Device Problems Device Dislodged or Dislocated (2923); Human-Device Interface Problem (2949); Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 04/19/2023

Event Type  malfunction  

Manufacturer Narrative

Block e1: initial reporter facility name: (b)(6).Block h6: imdrf device code a051201 captures the reportable event of device dislodged or dislocated.

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(emr) procedure performed on (b)(6) 2023.During the procedure, a polyp was removed with a snare.The endoscope was withdrawn, and it was noted that the clip had fallen off from the wound.Additionally, it was found that one of the clip arms was bent.The procedure was completed with another resolution 360 clip device.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 e1: initial reporter facility name: (b)(6).Block h2: additional information: h6 medical device problem code has been updated to a040609 to capture that this event will no longer be reportable.

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(emr) procedure performed on (b)(6) 2023.During the procedure, a polyp was removed with a snare.The endoscope was withdrawn, and it was noted that the clip had fallen off from the wound.Additionally, it was found that one of the clip arms was bent.The procedure was completed with another resolution 360 clip device.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 may 22, 2023: it was clarified that the pulling the scope out of the patient and they noticed the clip was 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: 16938934
• MDR Text Key: 315297900
• Report Number: 3005099803-2023-02496
• 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: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2023
• 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: 0030202664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2022
• 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 Age: 62 YR
• Patient Sex: Female
• Patient Weight: 50 KG