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

Model Number M00521421

Device Problems Use of Device Problem (1670); Activation, Positioning or Separation Problem (2906); Material Deformation (2976)

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

Event Date 02/01/2023

Event Type  malfunction  

Manufacturer Narrative

Imdrf device code a15 captures the reportable event of clip would not release from the catheter.

Event Description

Note: this report pertains to one resolution 360 ultra clip and one mantis used in the same patient and procedure.It was reported to boston scientific corporation that a mantis clip was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, the clip was able to grasp and lock onto tissue; however, the clip could not detach from the catheter to deploy.Additionally, the same issue occurred on the resolution 360 ultra clip device.The procedure was completed with another mantis clip device.There were no patient complications reported as a result of this event.Note: it was reported that the scope used was a duodenoscope.However, per the instructions for use, hemostasis clip is designed to be compatible with forward viewing endoscopes only.

Event Description

Note: this report pertains to one resolution 360 ultra clip and one mantis used in the same patient and procedure.It was reported to boston scientific corporation that a mantis clip was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, the clip was able to grasp and lock onto tissue; however, the clip could not detach from the catheter to deploy.Additionally, the same issue occurred on the resolution 360 ultra clip device.The scope used was an elevator scope (duodenoscope).The procedure was completed with another mantis clip device.There were no patient complications reported as a result of this event.Note: it was reported that the scope used was an elevator scope (duodenoscope).However, per the instructions for use, hemostasis clip is designed to be compatible with forward viewing endoscopes only.

Manufacturer Narrative

Block h6: imdrf device code a15 captures the reportable event of clip would not release from the catheter.Block h10: investigation results the returned mantis device was analyzed, and a visual evaluation noted that the device was returned without the clip assembly.It was also noted that the device had evidence of full deployment.Microscopic examination was performed, and it was found that the bushing had hit marks and the bushing was deformed.Dimensional examination was performed between the hooks of the bushing that both a and b sides were out of specifications.No other problems with the device were noted.The reported event of clip unable to release from the catheter was not confirmed.Investigation found that the device returned without the clip assembly and with evidence of full deployment.Evidence that the clip, did release.It is also important to mention that the presence of this component is very important to the investigation, this because the event reported is directly related to this piece, and to get a clarification of which could be the reason of the problem faced by the physician, this component must be inspected.The as reported code of "device use of device issue - misuse" will be confirmed since the customer stated that the device was used with a duodenoscope, not with a forward viewing scope.Additionally, it is important to take in consideration that during the product analysis, the dimensions between the hooks of the bushing were measured, and they were out of specification since the bushing was deformed.Excluding the possibility that this component was in that state since the manufacturing of the device.The returned device review showed no evidence of either the alleged(s) or any defect which could have contributed to the event.Therefore, the most probable root cause for this complaint is no problem detected.

• 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: 16428904
• MDR Text Key: 310254931
• Report Number: 3005099803-2023-00908
• 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,Followup
• Report Date: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/15/2023
• Device Model Number: M00521421
• Device Catalogue Number: 2142
• Device Lot Number: 0030158217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2022
• 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
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 61 KG
• Patient Race: White