MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESOLUTION CLIP; CLIP, HEMOSTATIC

Model Number	M00522600
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a resolution clip was used in the esophagus during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2023.During the procedure, the clip reached the lesion, but it was detached when it was prepared to be deployed.The procedure was completed with another resolution clip.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 Manufacturer Narrative
E1: (initial reporter address 2) (b)(6).H6: imdrf device code a150103 captures the reportable event of clip prematurely deployed.
Event or Problem Description
It was reported to boston scientific corporation that a resolution clip was used in the esophagus during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2023.During the procedure, the clip reached the lesion, but it was detached when it was prepared to be deployed.The procedure was completed with another resolution clip.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 Manufacturer Narrative
Block e1: (initial reporter address 2) (b)(6).Block h6: imdrf device code a150103 captures the reportable event of clip prematurely deployed.Block h10: investigation results: the returned resolution 360 clip device was analyzed, and a visual evaluation noted that the device was returned with the blue grip stuck into the clip assembly, also, the outer sheath was partially removed.No other problems with the device were noted.The reported event of clip premature deployment was not confirmed.Investigation found that the clip assembly was still attached, and without any evidence of detachment.The returned device review showed no evidence of either the alleged(s) or any defect which could have contributed to the event.Therefore, the most probable root cause for this complaint is no problem detected.In addition, the analyzed condition of the blue grip being stuck into the clip assembly will be classified as "failure to follow instructions" since it is evident that the sheath was attempted to be removed.

• Brand Name: RESOLUTION CLIP
• Common Device Name: CLIP, HEMOSTATIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18684238
• Report Number: 3005099803-2024-00409
• Device Sequence Number: 12569813
• Product Code: PKL
• UDI-Device Identifier: 08714729504764
• UDI-Public: 08714729504764
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K222503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2024

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 Expiration Date: 05/07/2025
• Device Model Number: M00522600
• Device Catalogue Number: 2260
• Device Lot Number: 0029455821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2024
• Supplement Date Received by Manufacturer: 03/01/2024
• Initial Report FDA Received Date: 02/12/2024
• Supplement Report FDA Received Date: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2022
• 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 Age: 63 YR
• Patient Sex: Female
• Patient Weight: 82 KG