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

Model Number M00521402

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

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

Event Date 10/14/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a resolution 360 ultra clip device was used in the colon during a colonoscopy procedure performed on (b)(6) 2022.During preparation the clip would not open.The procedure was completed with another resolution 360 ultra clip.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation findings 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 received with the clip assembly stuck into the bushing.Microscopic examination was performed and it was noticed that the bottom part of the clip assembly was deformed.The clip assembly has evidence of proper deployment, since it has both activations performed since the yoke was detached from the control wire.No other problems with the device were noted.Based on the condition of the returned device, the reported event of clip would not open was not confirmed.Investigation found that the clip assembly was highly stuck with the bushing, an evidence that match with a failure to release from the catheter.Reportedly, one of the possibilities that could have happened is that the amount of the tissue grasped was bigger than the clip could close, causing to apply an excess of force to close the clip arms in order to activate them, but due to the amount of tissue grasped, this force was enough to detach the clip from the bushing, but it was not to activate them.Due to this detachment, when the customer attempted to reposition the clip into the bushing, the clip got incorrectly positioned, and most likely the physician kept pulling back the clip and cause the control wire and clip detachment, causing a deployment failure.Additionally, the damages found on the clip assembly were caused most likely due to the entrapment against the bushing.Therefore, the most probable root cause is adverse event related to procedure, in order to address this failure on the capsule.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 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: 16067367
• MDR Text Key: 307026442
• Report Number: 3005099803-2022-07767
• Device Sequence Number: 1
• Product Code: PKL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K222503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/29/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 06/21/2024
• Device Model Number: M00521402
• Device Catalogue Number: 2140
• Device Lot Number: 0027540815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2022
• Initial Date FDA Received: 12/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2021
• 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