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

Model Number M00521232

Device Problems Activation, Positioning or Separation Problem (2906); Human-Device Interface Problem (2949)

Patient Problems Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/07/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a resolution 360 clip device was used during a colonoscopy procedure performed on (b)(6), 2022.During the procedure, the grasped and locked onto tissue, but did not release from the catheter to deploy.The clip was tried to open and close multiple times, clamping down to try and deploy again and pushed hand outwards to push clip off.It was noted that it ended up having to wiggle the clip off of the catheter multiple times and this cause some tearing off tissue.The device was then pulled out and when tested outside the patient, the clip would stick from the rest of the instrument until another 'deploy' movement was made which then leaves a very sharp end exposed.The procedure was completed with another resolution 360 clip and a resolution 360 ultra clip device.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: medical device problem code a15 captures the reportable event of clip difficult to release from catheter.Medical device problem code a22 captures the reportable event of exposed end of delivery catheter/control wire traumatic.Block h10: investigation results the returned resolution 360 clip device was analyzed, and a visual evaluation noted that the device was returned without the clip assembly and with evidence of full deployment.Microscopic examination was performed and it was found that the bushing had hit marks.It was also observed that the control wire looked normal with no sharp end.Dimensional analysis was performed on the bushing outer diameter, and it was found to be within specification.A dimensional analysis was also performed between the hooks of the bushing and the pin gage, and both were within specification.Dimensional analysis was performed to the square block and it was found to be rectangular.No other problems with the device were noted.Based on the condition of the returned device, the reported event of clip difficult to release from the catheter was confirmed.However the reported event of exposed sharp end of delivery catheter was not confirmed as there was no sharp end observed in the returned control wire.Investigation found that the bushing had hit marks which is likely due to the interaction between the yoke and the capsule.Regarding the tissue damage, this is known potential adverse event related with the use of the device and are noted within the ifu.Taking all available information into consideration, the most probable root cause of this event is manufacturing deficiency since the manufacturing review for this device revealed that a non-conformance was found related to the event of clip difficult to release from catheter occurred during manufacturing.An investigation to address this problem has been completed.A product labeling review identified that the device was used per the instructions for use (ifu)/product label.

Event Description

It was reported to boston scientific corporation that a resolution 360 clip device was used during a colonoscopy procedure performed on (b)(6) 2022.During the procedure, the grasped and locked onto tissue, but did not release from the catheter to deploy.The clip was tried to open and close multiple times, clamping down to try and deploy again and pushed hand outwards to push clip off.It was noted that it ended up having to wiggle the clip off of the catheter multiple times and this cause some tearing off tissue.The device was then pulled out and when tested outside the patient, the clip would stick from the rest of the instrument until another 'deploy' movement was made which then leaves a very sharp end exposed.The procedure was completed with another resolution 360 clip and a resolution 360 ultra clip device.There were no patient complications reported as a result of this event.

• 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: 13666801
• MDR Text Key: 286751594
• Report Number: 3005099803-2022-01122
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 08714729875642
• UDI-Public: 08714729875642
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151802
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/04/2023
• Device Model Number: M00521232
• Device Catalogue Number: 54774
• Device Lot Number: 0026390913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2020
• 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