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

Model Number M00522610

Device Problems Positioning Failure (1158); Activation, Positioning or Separation Problem (2906)

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

Event Date 10/01/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a resolution clip device was used during a colonoscopy procedure performed on an unknown date.During the procedure, the clip was able to grasp and lock onto tissue; however, the clip was unable to release from the catheter to deploy.The procedure was completed with another resolution clip device.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Date of event: approximated based on the date the manufacturer became aware of the event.(b)(4).

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event.Block h2: additional information: block b5 (describe event or problem) and block h6 (device code) have been updated based on the additional information received on november 3, 2022.Block h11: correction: additional information has been received on 01nov2022 stating that this was a clip unable to engage problem which is a non-reportable scenario.

Event Description

It was reported to boston scientific corporation that a resolution clip device was used during a colonoscopy procedure performed on an unknown date.During the procedure, the clip was able to grasp and lock onto tissue; however, the clip was unable to release from the catheter to deploy.The procedure was completed with another resolution clip device.There were no patient complications reported as a result of this event.Additional information received on november 3, 2022: it was clarified that the only device problem was the clip would not lock onto tissue.

• 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: 15708315
• MDR Text Key: 307523369
• Report Number: 3005099803-2022-06264
• Device Sequence Number: 1
• Product Code: MCH
• UDI-Device Identifier: 08714729504795
• UDI-Public: 08714729504795
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2022
• 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: 0028904824
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2022
• 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