MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESOLUTION 360 ULTRA CLIP; HEMOSTATIC METAL CLIP FOR THE GI TRACT

Model Number M00521401

Device Problems Activation, Positioning or Separation Problem (2906); Material Twisted/Bent (2981)

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

Event Date 06/12/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a resolution 360 ultra clip device was used during a procedure performed on (b)(6) 2022.It was reported that after three opening and closing of the device, the clip became twisted and therefore no longer on its axis.No patient complications have been reported as a result of this event.No further information has been obtained despite good faith efforts.This event has been deemed a reportable event based on the investigation finding of clip assembly stuck into the bushing.

Manufacturer Narrative

(b)(4).Investigation results the returned resolution 360 ultra clip device was analyzed, and a visual evaluation noted that the device was returned with the clip assembly stuck into the bushing.The handle had no communication with the clip assembly.Microscopic examination was performed and it was found that the capsule was deformed and the bushing had hit marks.Additionally, the yoke was returned inside the clip assembly, indicating both activations were performed.No other problems with the device were noted.The reported event of clip became twisted and therefore no longer on its axis was confirmed.It is possible that the amount of tissue grasped was bigger than the clip could close, causing the customer needed to apply an excessive force to close the clip arms, leading to the detachment of the clip from the bushing but not from the control wire.It is likely that the physician tried to reposition the clip after the clip detachment from the bushing, and this time an entrapment of the clip with the bushing was caused.Subsequently, when the customer keep pulling back the handle in an attempt to reposition the clip, this action induced that the capsule got localized incorrectly on the bushing; therefore, causing that the capsule and the bushing got stuck, and due to the force applied in order to release or reposition the clip, this generated that the yoke got detached from the control wire.Additionally, the hit marks found on the bushing is likely due to the interaction between the yoke and the capsule, in order to deploy the clip.It is important to highlight that during product analysis, the bushing and the capsule were separated requiring a lot of force, hence, this action could further aggravate these problems.Taking all available information into consideration, the most probable cause of this complaint is adverse event related to procedure because the adverse event occurred during the procedure and the device had no influence on the event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and from the information available, this device was used per the instructions for use (ifu)/product label.

• Brand Name: RESOLUTION 360 ULTRA CLIP
• Type of Device: HEMOSTATIC METAL CLIP FOR THE GI TRACT
• 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: 15536031
• MDR Text Key: 306508714
• Report Number: 3005099803-2022-05632
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 08714729997252
• UDI-Public: 08714729997252
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K151802
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00521401
• Device Catalogue Number: 2140
• Device Lot Number: 0028265260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1