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

Model Number 2261

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

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

Event Date 01/09/2023

Event Type  malfunction  

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 detached after being deployed.The procedure was completed with another resolution clip device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

(b)(4).

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 detached after being deployed.The procedure was completed with another resolution clip device.There were no patient complications reported as a result of this event.The patient 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 detached.Block h10: investigation results the returned resolution clip device was analyzed, and a visual evaluation noted that the device was returned with the clip assembly attached and the outer sheath was not returned with the device.Microscopic examination was performed, and it was found that the first activation was performed.Functional analysis noted that the clip assembly was able to perform the second activation and release the clip assembly.No other problems with the device were noted.The reported event of clip would not release from the catheter was not confirmed.Investigation found that the device was returned with the clip assembly still attached and with the first activation performed.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 labeling review was performed and from the information available, this device was used per the instructions for use (ifu)/product label.

• 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 CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16279586
• MDR Text Key: 308617672
• Report Number: 3005099803-2023-00355
• Device Sequence Number: 1
• Product Code: MCH
• 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
• Report Date: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2261
• Device Catalogue Number: 2261
• Device Lot Number: 0028096121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2021
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 72 KG