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

Model Number M00522600

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/07/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter facility name: (b)(6).(b)(4).

Event Description

It was reported to boston scientific corporation that a resolution clip device was used in the stomach during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2022.During the procedure, the clip was able to grasp and lock onto tissue; however, the clip could not be released from the catheter.The procedure was completed with another resolution clip device.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.

Manufacturer Narrative

: initial reporter facility name: east hospital of renji hospital, shanghai jiao tong university school of medicine medical device code a15 captures the reportable event of clip could not be released 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.The device was returned without the over-sheath.Microscopic examination was performed, and it was found that both of the clip arms were slightly bent.Functional evaluation was performed, and it could be observed that the device can open and close its arms within specification.Additionally, the clip assembly was able to perform the first activation and could be released from the catheter without problem.No other problems with the device were noted.The reported event of clip could not be released from catheter was not confirmed.It is possible that operational factors such as the amount of tissue grasped or the normal manipulation of the device during procedure could have caused the found problem of clip arms being bent.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.

Event Description

It was reported to boston scientific corporation that a resolution clip device was used in the stomach during an endoscopic submucosal dissection (esd) procedure performed on (b)(6), 2022.During the procedure, the clip was able to grasp and lock onto tissue; however, the clip could not be released from the catheter.The procedure was completed with another resolution clip device.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.

• Brand Name: RESOLUTION CLIP
• Type of Device: 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: 15544111
• MDR Text Key: 306419710
• Report Number: 3005099803-2022-05622
• Device Sequence Number: 1
• Product Code: MCH
• UDI-Device Identifier: 08714729504764
• UDI-Public: 08714729504764
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K040148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00522600
• Device Catalogue Number: 2260
• Device Lot Number: 0027465380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 65 KG