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	07/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a resolution clip device was used in the stomach during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2023.During the procedure, the clip was able to grasp and lock onto tissue; however, the clip was unable to release from the catheter to deploy.The clip eventually fell off during the attempted deployment process, and 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 a2: the patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block e1: initial reporter facility name: the second affiliated hospital of the chinese people's liberation army medical university.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 device was used in the stomach during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2023.During the procedure, the clip was able to grasp and lock onto tissue; however, the clip was unable to release from the catheter to deploy.The clip eventually fell off during the attempted deployment process, and 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 a2: the patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block e1: initial reporter facility name: the second affiliated hospital of the chinese people's liberation army army medical university block h6: imdrf device code a15 captures the reportable event of clip 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 without the clip assembly attached and with evidence of full deployment.The clip assembly was returned in a separate bag.Additionally, the device was returned without the over-sheath.Microscopic examination was performed, and it was found that the clip had both activations performed.No other problems with the device were noted.The reported event of clip unable to release from catheter was not confirmed.Investigation found that the device was returned without the clip assembly attached, the clip assembly was returned in a separate bag.Additionally, the device was returned with evidence of full deployment, indicating that the clip was properly deployed.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.

• 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: 17550037
• Report Number: 3005099803-2023-04249
• Device Sequence Number: 6939990
• 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): 09/29/2023

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: 09/28/2024
• Device Model Number: M00522600
• Device Catalogue Number: 2260
• Device Lot Number: 0028204982
• 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: 07/21/2023
• Supplement Date Received by Manufacturer: 09/04/2023
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2021
• 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