MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESOLUTION 360 CLIP; HEMOSTATIC METAL CLIP FOR THE GI TRACT

Model Number M00521231

Device Problems Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 12/12/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to boston scientific corporation that a resolution 360 clip device was used for a minor bleeding during a gastroscopy procedure performed on (b)(6) 2022.During the procedure, the clip was able to grasp and lock onto tissue; however, the clip was impossible to release from the catheter.It was reported that when the device was removed from the tissue, a minor mucosal tear occurred.Another resolution 360 clip was placed to treat the mucosal tear and the procedure was completed at this time.The patient condition following the procedure was reported to be good.

Manufacturer Narrative

Block h2: additional information: b5 (describe event or problem) block h6: imdrf device code a15 captures the reportable event of clip impossible to release from the catheter.Block h11: a2 (age at time of event) and (unit of measure - age) correction: block h11: correction to field g4: premarket / 510(k) has been corrected.

Event Description

It was reported to boston scientific corporation that a resolution 360 clip device was used for a minor bleeding during a gastroscopy procedure performed on (b)(6) 2022.During the procedure, the clip was able to grasp and lock onto tissue; however, the clip was impossible to release from the catheter.It was reported that when the device was removed from the tissue, a minor mucosal tear occurred.Another resolution 360 clip was placed to treat the mucosal tear and the procedure was completed at this time.The patient condition following the procedure was reported to be good.***additional information received on 10jan2023*** the anatomy location was stomach.

Manufacturer Narrative

Block h2: additional information: b5 (describe event or problem).Block h6: imdrf device code a15 captures the reportable event of clip impossible to release from the catheter.Block h10: investigation results: the returned resolution 360 clip device was analyzed, and a visual evaluation noted that the device was returned with the clip assembly attached.Microscopic examination was performed, and it was found that one of the clip arms was bent and the other arm was already activated.Additionally, it was observed that the yoke was detached from the control wire and the tension breaker had an indentation.Functional evaluation was performed, and it was found that the handle does not have communication with the clip assembly.No other problems with the device were noted.With all the available information, boston scientific corporation concludes that the reported event of clip impossible to release from catheter was confirmed.It is possible that the amount of tissue grasped was bigger than the clip could close, causing the customer needed to apply an excessive force to close the clip arms in order to activate them.However, due to the amount of tissue grasped, this force was enough to detach the control wire from the yoke, but it was not to detach the clip assembly from the bushing.Regarding the found problems of clip arms being bent and indentation on the tension breaker, this could have been due to a high tangential asymmetric load applied to only one side of the clip that creates an indentation on the tension breaker and increase the tension breaker yoke join elongation.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.A labeling review was performed and from the information available, this device was used per the instructions for use (ifu)/product label.Block h11: correction: a2 (age at time of event) and (unit of measure - age).Block h11: correction to field g4: premarket / 510(k) has been corrected.Block h11: correction: d4 (model number) has been corrected.

Event Description

It was reported to boston scientific corporation that a resolution 360 clip device was used for a minor bleeding during a gastroscopy procedure performed on (b)(6) 2022.During the procedure, the clip was able to grasp and lock onto tissue; however, the clip was impossible to release from the catheter.It was reported that when the device was removed from the tissue, a minor mucosal tear occurred.Another resolution 360 clip was placed to treat the mucosal tear and the procedure was completed at this time.The patient condition following the procedure was reported to be good.

• Brand Name: RESOLUTION 360 CLIP
• 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: 16142766
• MDR Text Key: 308748677
• Report Number: 3005099803-2022-08083
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 08714729875635
• UDI-Public: 08714729875635
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K151802
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00521231
• Device Catalogue Number: 54773
• Device Lot Number: 0029695770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2022
• 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: 62 YR