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

Model Number M00521420

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 03/01/2024

Event Type  malfunction  

Manufacturer Narrative

Block b3: the date of the event was approximated to (b)(6) 2024 based on the date the manufacturer became aware of the event.Block d4, h4: the complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.Block h6: imdrf device code a15 captures the reportable event clip that would not deploy.

Event Description

Note: this report pertains to the first of two mantis clip devices used in the same patient and procedure.It was reported to boston scientific corporation that two mantis clips devices were used during a procedure performed on an unknown date.During the procedure, the clip would not deploy all the way.Additionally, the same problem occurred on the other mantis clip device.There were no patient complications have been 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: 19004188
• MDR Text Key: 339148415
• Report Number: 3005099803-2024-01336
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 00191506023591
• UDI-Public: 00191506023591
• 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: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00521420
• Device Catalogue Number: 2142
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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