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

Model Number M00522612

Device Problems Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907); Human-Device Interface Problem (2949); Material Deformation (2976)

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

Event Date 10/17/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2022 as the event date occurred during the week of (b)(6) 2022.(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 stuck into the bushing.The device was returned without the over-sheath.Microscopic examination was performed, and it was found that the capsule bottom part was damaged.Additionally, the locking tabs were opened.No other problems with the device were noted.A photo of the device inside the original pouch was reviewed and no problems were observed.The reported event of clip poor bite was not 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 in order to activate them.However, due to the amount of tissue grasped, this force was enough to detach the clip from the bushing, but it was not enough to activate them.Subsequently, due to this detachment, when the customer attempted to reposition the clip into the bushing, the clip got incorrectly positioned.Additionally, it is most likely that the physician kept pulling back the clip and cause the control wire and clip detachment, causing a deployment problem.Regarding the damages found on the clip assembly, this is likely due to the entrapment against the bushing.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.

Event Description

It was reported to boston scientific corporation that a resolution clip device was used during a colonoscopy procedure performed during the week of (b)(6) 2022, though the exact date is unknown.During the procedure, the clip would not lock and would fall off the tissue.The procedure was completed with another resolution 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 finding of clip assembly stuck into the bushing.

• Brand Name: RESOLUTION CLIP CLIPPING DEVICE
• 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: 16097071
• MDR Text Key: 306845413
• Report Number: 3005099803-2022-07806
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 08714729504818
• UDI-Public: 08714729504818
• 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: Nurse
• Type of Report: Initial
• Report Date: 01/04/2023

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 Model Number: M00522612
• Device Catalogue Number: 2261
• Device Lot Number: 0029709028
• 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: 12/07/2022
• Initial Date FDA Received: 01/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2022
• 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