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

Model Number	M00522600
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: the reported health care facility is (b)(6).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 clip was used in the stomach for a gastric ulcer bleeding during a gastric ulcer hemostasis procedure performed on (b)(6) 2024.During the procedure and inside the patient, when the clip captured the tissue and closed, the arms were bent and could not be recaptured or deployed as expected.The procedure was completed with another of the same device.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 e1: the reported health care facility is (b)(6).Block h6: imdrf device code a15 captures the reportable event of clip unable to release from catheter.Block h11: a resolution clip was received for analysis.Visual inspection of the returned device revealed that the clip assembly was detached and with the arms bent.No other problems were noted.The reported complaint of clip failure to release from catheter was unable to be confirmed since the device was returned fully deployed.However, during product analysis, it was found that the clip arms were bent.It is likely that the customer would try to grasp a large amount of tissue, bigger than the clip could close.This action can cause a deformation in the distal section of the clip arm affecting the capability closing its jaws correctly and consequently the capability to remain attached to the tissue.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is adverse event related to procedure since there were operational factors that could lead to the malfunction of the device.
Event or Problem Description
It was reported to boston scientific corporation that a resolution clip was used in the stomach for a gastric ulcer bleeding during a gastric ulcer hemostasis procedure performed on (b)(6) 2024.During the procedure and inside the patient, when the clip captured the tissue and closed, the arms were bent and could not be recaptured or deployed as expected.The procedure was completed with another of the same device.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: 20016489
• Report Number: 3005099803-2024-03893
• Device Sequence Number: 20982803
• 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): 10/15/2024

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: 04/16/2026
• Device Model Number: M00522600
• Device Catalogue Number: 2260
• Device Lot Number: 0031442693
• 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: 07/24/2024
• Supplement Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2023
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 75 KG