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

Model Number	M00522600
Medical Device Problem Codes	Premature Activation (1484); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: imdrf device code a150103 captures the reportable event of clips premature deployment.
Event or Problem Description
It was reported to boston scientific corporation that a resolution clip was used for surgical closure of the wound to stop bleeding during an endoscopic submucosal dissection (esd) wound closure procedure performed on (b)(6) 2024.During preparation, when the physician opened the package, the front part of the clip fell off.The procedure was completed with another resolution clip.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a150103 captures the reportable event of clips premature deployment.Block h11: investigation results: a resolution clip was received for analysis.Visual and microscopic inspection of the returned device revealed without the outer sheath and clip assembly.In addition, device has evidence of premature deployment since the yoke is still attached to the control wire.No other problems were noted.The reported complaint of clip premature deployment was confirmed since the device was returned with evidence of premature deployment.Upon product analysis it was observed that the device was returned without the clip assembly but with the yoke ball still attached, however it was reported that the device was not used in a procedure.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is cause not established.
Event or Problem Description
It was reported to boston scientific corporation that a resolution clip was used for surgical closure of the wound to stop bleeding during an endoscopic submucosal dissection (esd) wound closure procedure performed on (b)(6) 2024.During preparation, when the physician opened the package, the front part of the clip fell off.The procedure was completed with another resolution clip.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.

• 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; propark, coyol; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 20201441
• Report Number: 3005099803-2024-04362
• Device Sequence Number: 15340027
• 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): 11/14/2024

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): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2024
• Supplement Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 11/14/2024
• 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 Sex: Unknown