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

Model Number	M00522600
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: (b)(6).Block h6: imdrf device code a15 captures the reportable event of clip was unable to release from catheter.
Event or Problem Description
It was reported to boston scientific corporation that a resolution clip device was used in the stomach during an endoscopic treatment procedure performed on (b)(6) 2023.During the procedure, the device could grasp, close and lock onto tissue and was eventually unable to release.The procedure was completed with another resolution clip.There were no patient complications reported as a result of this event.The patient's condition after the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation that a resolution clip device was used in the stomach during an endoscopic treatment procedure performed on (b)(6), 2023.During the procedure, the device could grasp, close and lock onto tissue and was eventually unable to release.The procedure was completed with another resolution clip.There were no patient complications reported as a result of this event.The patient's condition after the procedure was reported to be stable.
Additional Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6) hospital.Block h6: imdrf device code a15 captures the reportable event of clip was unable to release from catheter.Block h10: investigation results: the returned resolution clip device was analyzed, and a visual evaluation noted that the device was returned with the clip assembly attached.Additionally, both of the clip arms were bent.Microscopic examination was performed, and it was found that the yoke was detached from the control wire, but the clip was still attached to the delivery system.Functional evaluation was performed, and it was found that the handle does not have communication with the clip assembly.No other problems with the device were noted.The reported event of clip unable to release from catheter was not confirmed.It is possible that the customer tried to grasp a large amount of tissue, and this action can cause a deformation in the distal section of the clip arm, affecting the capability of the jaws of the clip to close correctly.Moreover, it is important to mention that applying tangential pressure to an opened or closed clip may result in the clip separating from the catheter and potentially kinking or damaging the device.Taking all available information into consideration, the most probable cause of this complaint is adverse event related to procedure because the adverse event occurred during the procedure and the device had no influence on the event.

• 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 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: 17649998
• Report Number: 3005099803-2023-04650
• Device Sequence Number: 17945207
• 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): 11/02/2023

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: 02/26/2025
• Device Model Number: M00522600
• Device Catalogue Number: 2260
• Device Lot Number: 0029041003
• 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: 08/09/2023
• Supplement Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 08/30/2023
• Supplement Report FDA Received Date: 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2022
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 52 KG