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); Difficult to Open or Close (2921); Material Deformation (2976)

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

Event Date 07/19/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the device analysis, 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 in the stomach during a colonoscopy procedure performed on (b)(6) 2022.During the procedure, the clip was able to grasp and lock onto tissue; however, the clip did not fully detached from the catheter to deploy.The procedure was completed with another resolution 360 clip device.It was reported that there was abnormally high resistance felt before the spool reached the end of the stroke and the coil catheter was noted kinked.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block h6: medical device problem code a15 captures the reportable event of clip did not fully detached from catheter.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.Additionally, the device did not had any evidence of a kink.Microscopic examination was performed, and it was found that the bushing had hit marks on both hooks.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 both sides were confirmed to be within specification.No other problems with the device were noted.The reported event of clip did not fully detach from catheter was not confirmed.Investigation found that the bushing had hit marks, this is likely due to the interaction between the yoke and the capsule, in order to deploy the clip.The device was returned without the clip assembly, and it is important to mention that the presence of this component is very important to the investigation in order to analyze any failure that could contribute with the problem faced by the physician.The investigation findings and all information available do not lead to a clear conclusion about the cause of the reported adverse event.Therefore, the most probable root cause is cause not established.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

Event Description

It was reported to boston scientific corporation that a resolution 360 clip device was used in the stomach during a colonoscopy procedure performed on (b)(6) 2022.During the procedure, the clip was able to grasp and lock onto tissue; however, the clip did not fully detached from the catheter to deploy.The procedure was completed with another resolution 360 clip device.It was reported that there was abnormally high resistance felt before the spool reached the end of the stroke and the coil catheter was noted kinked.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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: 15306124
• MDR Text Key: 302837839
• Report Number: 3005099803-2022-04809
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 08714729875642
• UDI-Public: 08714729875642
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/08/2023
• Device Model Number: M00521232
• Device Catalogue Number: 54774
• Device Lot Number: 0025633298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2020
• 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
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 65 KG