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

Model Number	M00522600
Medical Device Problem Codes	Premature Activation (1484); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block 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) 2024.During the procedure, the clip detached when the clip 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.
Event or Problem Description
It was reported to boston scientific corporation that a resolution clip was used for hemostasis in the esophagus during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2023.During the procedure, the clip detached when the clip 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 information was received on february 19, 2024, that the clip could not lock onto tissue.It fell off when it was about to be deployed.
Additional Manufacturer Narrative
Correction: additional information was received from the complainant on february 19, 2024, stating that the clip could not lock onto the tissue.It fell off when it was about to be deployed.Due to the additional information received, the event is no longer considered reportable.Block e1: (initial reporter address 2) (b)(6).Blocks b5, e1 and h6 have been updated based on additional information received february 19, 2024.Block h10: investigation results the returned resolution 360 clip device was analyzed, and a visual evaluation noted that the device was returned with the clip assembly attached and with the blue grip stuck into the clip assembly.No other problems with the device were noted.The reported event of clip poor bite was not confirmed.Investigation found that the device was returned the clip assembly attached and with the blue grip stuck into the clip assembly.A labeling review was performed and from the information available, this device was not used per the instructions or use (ifu)/product label.Per ifu, "once the resolution clip can be observed exiting the tip of the endoscope under direct visualization, remove the stopper located between the over-sheath grip and the handle as shown in figure 1.To fully expose the resolution clip jaws, hold the over-sheath grip and push the handle distally until handle rests against the over-sheath grip, as shown in figure 2." the conclusion is acceptable because the analysis of the available information, product analysis of the returned device and product record review did not identify any evidence of either the alleged issue(s) or any defect on the device.Also, the evidence from the product record review did not identify a potential product quality issue or new patient harm.All compiled information on this investigation determines that the most probable cause is no problem detected.Block h11: correction.Block b5 has been updated due to the year indicated.

• 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: 18675674
• Report Number: 3005099803-2024-00407
• Device Sequence Number: 20660129
• 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): 03/15/2024

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: 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: 02/19/2024
• Initial Report FDA Received Date: 02/09/2024
• Supplement Report FDA Received Date: 03/15/2024
• 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