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

Model Number M00521421

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 05/01/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a15 captures the reportable event of clip unable to deploy.

Event Description

It was reported to boston scientific corporation that a mantis clip device was used during a colonoscopy procedure performed on (b)(6) 2023.During the procedure, the clip was able to grasp and lock onto tissue; however, the clip was unable to release from the catheter to deploy.The procedure was completed with a non bsc 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.

Manufacturer Narrative

Block h6: imdrf device code a15 captures the reportable event of clip unable to deploy.Block h10: investigation results the returned mantis clip device was analyzed, and a visual evaluation noted that the device was returned with the clip assembly stuck into the bushing.Microscopic examination was performed, and it was found that the clip assembly was deformed, and the catheter was cut in two pieces.Additionally, the clip assembly had evidence of both activations being performed.Dimensional analysis was performed between the hooks of the bushing and side a was found to be within specification while side b was out of specification.No other problems with the device were noted.The reported event of clip would not release from catheter was confirmed.Investigation found evidence that match with a failure to release the clip from the catheter due to the clip assembly 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 failure.The damages found on the clip assembly were caused most likely due to the entrapment against the bushing.Additionally, the failure modes found on the bushing of the dimensions out of specification and the hits on the hooks could have been caused when the capsule and the bushing got stuck.Therefore, it is important to highlight that during product analysis the bushing and capsule were separated requiring a lot of force, hence, this action could further aggravate these failures.The analyzed condition of the catheter being cut in two pieces could have been caused by the adversities faced by the physician during the deployment attempts.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 mantis clip device was used during a colonoscopy procedure performed on may 1, 2023.During the procedure, the clip was able to grasp and lock onto tissue; however, the clip was unable to release from the catheter to deploy.The procedure was completed with another mantis 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.

• Brand Name: MANTIS
• 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: 16993342
• MDR Text Key: 315855197
• Report Number: 3005099803-2023-02710
• Device Sequence Number: 1
• Product Code: PKL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221124
• 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,Followup
• Report Date: 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2023
• Device Model Number: M00521421
• Device Catalogue Number: 2142
• Device Lot Number: 0030536353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2022
• 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