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

Model Number M00522612

Device Problems Failure to Advance (2524); Activation, Positioning or Separation Problem (2906)

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

Event Date 04/11/2023

Event Type  malfunction  

Manufacturer Narrative

Imdrf device code a15 captures the reportable event of clip would not fully release from catheter.

Event Description

Note: this report pertains to one of two resolution clips used in the same patient and procedure.It was reported to boston scientific corporation that two resolution clip devices were used during a colonoscopy procedure performed on (b)(6) 2023.During the procedure, the clip was able to close and lock onto tissue; however, the clip would not fully release from the catheter to deploy.The same problem occurred with the second resolution clip.The procedure was completed with another resolution clip.It was reported that the technician felt some resistance and had to use more force than usual to advance the clips out of the over-sheath.There were no patient complications reported as a result of this event.

• Brand Name: RESOLUTION CLIP CLIPPING DEVICE
• 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: 16863415
• MDR Text Key: 314918580
• Report Number: 3005099803-2023-02255
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 08714729504818
• UDI-Public: 08714729504818
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K222503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00522612
• Device Catalogue Number: 2261
• Device Lot Number: 0030526891
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2022
• 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