MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESOLUTION CLIP; CLIP, HEMOSTATIC

Model Number M00522610

Device Problems Use of Device Problem (1670); Activation, Positioning or Separation Problem (2906); Difficult to Open or Close (2921); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 04/26/2023

Event Type  malfunction  

Manufacturer Narrative

Imdrf device code a15 captures the reportable event of clip could not be deployed.

Event Description

It was reported to boston scientific corporation that a resolution clip device was used in the colon during an endoscopic mucosal resection (emr) procedure performed on (b)(6) 2023.During the procedure, the clip could not be deployed.The procedure was completed with another resolution clip.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: imdrf device code a15 captures the reportable event of clip could not be deployed.

Event Description

It was reported to boston scientific corporation that a resolution clip device was used in the colon during an endoscopic mucosal resection (emr) procedure performed on (b)(6) 2023.During the procedure, the clip could not be deployed.The procedure was completed with another resolution clip.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.Additional information received on may 18, 2023: it was reported that the clip was able to grasp and lock onto tissue; however, the clip was unable to release from the catheter to deploy.Additionally, there was abnormally high resistance felt before the handle spool reached the end of the stroke and the catheter was noted kinked.Additional information received on may 22, 2023: note: it was reported that the sheath was completely remove off the device before entering the scope.However, per the instructions for use, the over sheath is supposed to be retracted to expose the clip and not removed from the catheter.

Manufacturer Narrative

Block h6: imdrf device code a15 captures the reportable event of clip could not be deployed.Investigation results: the returned resolution clip device was analyzed, and a visual evaluation noted that the device was returned without the clip assembly and with evidence of full deployment.The device was returned without the over-sheath.Additionally, there were no kinks found on the device.Microscopic examination was performed, and it was confirmed that the device had evidence of full deployment.Dimensional analysis was performed between the hooks of the bushing and both sides were noted to be within specification.No other problems with the device were noted.The reported event of clip could not be deployed was not confirmed.Investigation found that the device was returned without the clip assembly and with evidence of full deployment, indicating that the clip did release from the catheter.However, it is important to mention that the presence of the clip assembly is very important to the investigation in order to analyze any failure that could contribute with the problem faced by the physician.Additionally, it is important to take into consideration that during the product analysis, the dimensions between the hooks of the bushing were measured, and they were within specification, excluding the possibility that the device components dimensions interfered with the device performance.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.A product labeling review identified that the device was not used per the instructions for use (ifu)/product label as it was reported that the over-sheath was attempted to be completely removed from the device which is not describe in the instructions for use.

Event Description

It was reported to boston scientific corporation that a resolution clip device was used in the colon during an endoscopic mucosal resection (emr) procedure performed on (b)(6) 2023.During the procedure, the clip could not be deployed.The procedure was completed with another resolution clip.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.Additional information received on may 18, 2023: it was reported that the clip was able to grasp and lock onto tissue; however, the clip was unable to release from the catheter to deploy.Additionally, there was abnormally high resistance felt before the handle spool reached the end of the stroke and the catheter was noted kinked.Additional information received on may 22, 2023: note: it was reported that the sheath was completely remove off the device before entering the scope.However, per the instructions for use, the over sheath is supposed to be retracted to expose the clip and not removed from the catheter.

• Brand Name: RESOLUTION CLIP
• Type of Device: CLIP, HEMOSTATIC
• 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: 16947155
• MDR Text Key: 315461655
• Report Number: 3005099803-2023-02663
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 08714729504795
• UDI-Public: 08714729504795
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K222503
• 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,Followup
• Report Date: 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00522610
• Device Catalogue Number: 2261
• Device Lot Number: 0028125482
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2021
• 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: 67 YR
• Patient Sex: Male
• Patient Weight: 72 KG