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

Model Number M00521421

Device Problems Positioning Failure (1158); Use of Device Problem (1670); Difficult to Open or Close (2921); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 12/06/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code (b)(6) captures the reportable investigation results of clip assembly stuck into the bushing.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 capsule bottom part was damaged.No other problems with the device were noted.Investigation found that it is most likely that as part of the device manipulation during procedure due to procedural factors a partial separation of the clip happened, probably due to a tangential force applied during the clip maneuvering and once the clip assembly is detached from the bushing, the device loose its functionality.While the physician kept pulling back the handle in order to re position the clip assembly, this technique generated that the yoke got detached from the control wire.And this entrapment also contributed to the deformation found on the clip assembly.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 colonoscopy procedure performed on (b)(6) 2023.During the procedure, the physician closed the clip on one side of defect and then asked the nurse to reopen the clip.However, the clip did not reopen.Using traction, the clip was removed from the side of the defect and was then removed from the scope.The procedure was completed with another mantis 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 findings of clip assembly stuck into the bushing.Please see block h10 for full investigation details.

• 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: 18739151
• MDR Text Key: 336788745
• Report Number: 3005099803-2024-00513
• Device Sequence Number: 1
• Product Code: PKL
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K221124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• 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: 0031570955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2024
• Date Device Manufactured: 05/08/2023
• 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