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

Model Number M00521231

Device Problems Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 12/20/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a resolution clip device was used for bleeding during a colonoscopy procedure performed on (b)(6) 2023.During the procedure, the clip would not release from the catheter.The physician attempted to dislodge the clip, opening and closing the handle, rotating, pushing the handle forward, placing it at the end of the scope at the wound, and pulling again, but was unsuccessful.There was great concern about causing additional bleeding or injury just by ripping the clip off of the wound, however, fortunately, in the process of rotating and pulling the clip did come off of the wound creating only minimal tissue damage.Nothing of significant consequence to the patient.The clip remained on the catheter; however, it was not at the same angle when it was first opened.The procedure was completed with another resolution clip device.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: imdrf device code a15 captures the reportable event of clip wold not release.

Manufacturer Narrative

Imdrf device code a15 captures the reportable event of clip would not release.Block h10: investigation results the returned resolution 360 clip device was analyzed, and it was noted that the device was returned with the clip assembly stuck into the bushing and with the clip assembly bottom part deformed.No other problems with the device were noted.The reported event of clip would not release was confirmed.Investigation found that this is due to the clip assembly that was highly stuck with the bushing.According to the evidence, one of the possibilities that could have happened is that the amount of the tissue grasped was bigger than the clip could close, causing that the customer needed 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 problem.Also, the damages found on the clip assembly were caused most 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 for bleeding during a colonoscopy procedure performed on (b)(6) 2023.During the procedure, the clip would not release from the catheter.The physician attempted to dislodge the clip, opening and closing the handle, rotating, pushing the handle forward, placing it at the end of the scope at the wound, and pulling again, but was unsuccessful.There was great concern about causing additional bleeding or injury just by ripping the clip off of the wound, however, fortunately, in the process of rotating and pulling the clip did come off of the wound creating only minimal tissue damage.Nothing of significant consequence to the patient.The clip remained on the catheter; however, it was not at the same angle when it was first opened.The procedure was completed with another resolution clip device.There were no patient complications reported as a result of this event.

• Brand Name: RESOLUTION 360 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: 18714453
• MDR Text Key: 336537792
• Report Number: 3005099803-2024-00347
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 08714729875635
• UDI-Public: 08714729875635
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K222503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00521231
• Device Catalogue Number: 54773
• Device Lot Number: 0031704547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2023
• 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