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

Model Number M00522612

Device Problems Break (1069); Activation, Positioning or Separation Problem (2906)

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

Event Date 08/23/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

This report pertains to one of two resolution clip devices 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) 2022.During the procedure, the clip was attempted to be deployed; however, the clip would not deploy accurately.The clip eventually release from the catheter after manipulation.The same issue occurred with the second resolution clip device.The procedure was completed with another resolution clip device.It was reported that the control wire was broken.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: 15454590
• MDR Text Key: 306269149
• Report Number: 3005099803-2022-05256
• Device Sequence Number: 1
• Product Code: MCH
• UDI-Device Identifier: 08714729504818
• UDI-Public: 08714729504818
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040148
• 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: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 0029133429
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/23/2022
• Initial Date FDA Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2022
• 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