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

Model Number M00521421

Device Problems Break (1069); Unraveled Material (1664); Activation, Positioning or Separation Problem (2906)

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

Event Date 01/09/2024

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a15 captures the reportable event of clip could not deploy.

Event Description

It was reported to boston scientific corporation that a mantis clip device was used for closure in the cecum during an endoscopic mucosal resection (emr) procedure performed on (b)(6) 2024.During the procedure, the clip was able to grasp and lock onto tissue; however, the clip could not detach from the catheter to deploy.The physician attempted every method to remove the clip while it was still in place.The handle broke upon deployment.The physician ended up cutting the clip at the handle, removed the scope, going side by side and broke the clip by applying pressure using a grasper.The clip eventually released from the catheter.The device detached above the usual deployment hub instead of where it was supposed to.The procedure was completed with another mantis clip device.There were no patient complications reported as a result of this event.

• 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: 18621450
• MDR Text Key: 334293681
• Report Number: 3005099803-2024-00252
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 00191506023607
• UDI-Public: 00191506023607
• 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
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00521421
• Device Catalogue Number: 2142
• Device Lot Number: 0032333391
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2023
• 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