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

Model Number	M00522600
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.(initial reporter last name): (b)(6).(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
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) 2021.During the procedure, the clip grasped and locked onto tissue and when trying to deploy the clip, it did not release from the catheter.Another attempt was made and the front end of the clip detached.The procedure was completed with another resolution clip device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block e1 (initial reporter last name): the (b)(6) university block h6: medical device problem 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 clip assembly was not returned with the device, indicating an evidence that the device was prematurely deployed.The device was returned without its over sheath.Microscope examination was performed, and it was observed that the bushing had hit marks on its surface could likely due to the interaction between the yoke and the capsule, in order to make the deployment of the clip.It was also found that the clip assembly had been activated.Additionally, the clip arms were bent.No other problems with the device were noted.The reported event was not confirmed.This failure is likely due to factors or conditions related to procedure during the use of the device that could have affected its performance and its intended purpose.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
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) 2021.During the procedure, the clip grasped and locked onto tissue and when trying to deploy the clip, it did not release from the catheter.Another attempt was made and the front end of the clip detached.The procedure was completed with another resolution clip device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of 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 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: 13250519
• Report Number: 3005099803-2021-08240
• Device Sequence Number: 17292794
• Product Code: MCH
• UDI-Device Identifier: 08714729504764
• UDI-Public: 08714729504764
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K040148
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2022

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: 01/28/2023
• Device Model Number: M00522600
• Device Catalogue Number: 2260
• Device Lot Number: 0025206961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/15/2021
• Supplement Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 01/13/2022
• Supplement Report FDA Received Date: 02/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2020
• 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