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

Model Number	M00521240
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the lot number of the suspect device.Therefore, the manufacture and expiration dates are unknown.Block h6: imdrf device code a15 captures the reportable event of clip unable to release from catheter.
Event or Problem Description
It was reported to boston scientific corporation that a resolution 360 clip was used in the ascending colon for post polypectomy during a colonoscopy procedure performed on (b)(6) 2024.During the procedure and inside the patient, the scope was in a difficult/twisted position.The clip was passed down the scope but was being placed at a severe angle due to the anatomy and scope position.The clip was able to be closed and deployed, but the bushing would not separate from the capsule.The handle could be articulated and remove the catheter, but no movement occurred.The physician removed the entire clip by avulsing the closed clip from the tissue.The procedure was completed with another resolution 360 clip.There were no patient complications reported as a result of this event.Note: the complainant reported that the device was used in a tortuous anatomy.However, according to the directions for use (dfu), "passage of the resolution 360 clip through a retroflexed or tortuous path, may result in the clip separating from the catheter and potentially kinking or damaging the device.".

• Brand Name: RESOLUTION 360 CLIP
• Common Device Name: 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 CORPORATION; 2546 calle primera; propark, coyol; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 19392499
• Report Number: 3005099803-2024-02405
• Device Sequence Number: 17879096
• Product Code: PKL
• UDI-Device Identifier: 08714729875666
• UDI-Public: 08714729875666
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K222503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00521240
• Device Catalogue Number: 54772
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2024
• Initial Report FDA Received Date: 05/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown