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

Model Number M00522610

Device Problems Activation, Positioning or Separation Problem (2906); Difficult to Open or Close (2921); Material Deformation (2976)

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

Event Date 02/21/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation results the returned resolution clip device was analyzed, and a visual evaluation noted that the device was returned with the clip assembly attached.Microscopic examination was performed and it was found that the clip assembly had both activations performed.It was also observed that the clip assembly was stuck into the bushing and the clip assembly had evidence of flaring.The capsule bottom part was widened with evidence of flaring into the bushing.Additionally, the bushing had hit marks and the bushing tabs were rounded.Dimensional analysis was performed on the bushing outer diameter, and it was found to be within specification.A dimensional analysis was also performed between the hooks of the bushing and the pin gage, and both were confirmed to be out of specification.No other problems with the device were noted.Based on the condition of the returned device, the reported event of clip unable to deploy.Investigation found that the hooks of the bushing were out of specification and the capsule tabs were rounded with evidence of flaring of the capsule into the bushing which can be traced to the manufacturing process as a contributing factor and could contribute to a clip deployment problem.Additionally, the hit marks found on the bushing is likely due to the flaring of the capsule onto the bushing.Taking all available information into consideration, the most probable root cause of this event is manufacturing deficiency, as the reported event was traced to the manufacturing process.An investigation to address this problem is in progress.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

Event Description

It was reported to boston scientific corporation that a resolution clip device was used in the intestine during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2022.During the procedure, it was noticed that the device could not be closed.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.This event has been deemed a reportable event based on the investigation findings of bushing hooks were out of specification and the bushing tabs were rounded.

• 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: 14207909
• MDR Text Key: 290070459
• Report Number: 3005099803-2022-02300
• Device Sequence Number: 1
• Product Code: MCH
• UDI-Device Identifier: 08714729504795
• UDI-Public: 08714729504795
• 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
• Report Date: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2023
• Device Model Number: M00522610
• Device Catalogue Number: 2261
• Device Lot Number: 0025083543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2020
• 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: 78 YR
• Patient Sex: Male
• Patient Weight: 63 KG