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 02/14/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a resolution clip device was used in the stomach during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, the tip of the device could not be opened smoothly.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.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, causing deployment problem.

Manufacturer Narrative

(b)(4).Investigation results: the returned resolution clip device was analyzed, and a visual evaluation noted that the device was received with the clip assembly attached and the outer-sheath was not returned with the device.Microscopic examination was performed and it was found that the clip arms were misaligned and the capsule was stuck into the bushing.It was also observed that the bottom part of the capsule was widened.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 difficult to open was not confirmed.Investigation found that the hooks of the bushing were out of specification and the capsule tabs were rounded and with evidence of flaring of the capsule into the bushing which can be traced to the manufacturing process as a contributing factor and may have contributed 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.Therefore, the most probable root cause 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.

• 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: 14112950
• MDR Text Key: 289279524
• Report Number: 3005099803-2022-02014
• 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: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/13/2022
• Device Model Number: M00522610
• Device Catalogue Number: 2261
• Device Lot Number: 0024849668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2019
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 78 KG