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

Model Number M00522612

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 05/11/2022

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 (b)(4) 2022.During the procedure after the clip was inserted down scope, it was noticed that the clip would not deploy.The procedure was completed with another resolution clip device.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.

Manufacturer Narrative

Medical device problem code a15 captures the reportable event of clip would not deploy.The device has not been received for analysis.Upon receipt and completion of the device analysis, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Manufacturer Narrative

Block h6: medical device problem code a15 captures the reportable event of clip would not deploy.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.Microscopic examination was performed, and no problems were found on the device.Functional evaluation was performed, and it could be observed that the device can open and close its arms within specification.Additionally, the clip assembly was able to perform the first activation and could be released from the catheter without problem.No problems with the device were noted.The reported event of clip would not deploy was not confirmed.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 review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

Event Description

It was reported to boston scientific corporation that a resolution clip device was used during a colonoscopy procedure performed on (b)(6) 2022.During the procedure after the clip was inserted down scope, it was noticed that the clip would not deploy.The procedure was completed with another resolution clip device.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.

• 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: 15293213
• MDR Text Key: 305346075
• Report Number: 3005099803-2022-04816
• 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,Followup
• Report Date: 10/31/2022

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: 0028027371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/04/2022
• Initial Date FDA Received: 08/25/2022
• Supplement Dates Manufacturer Received: 10/04/2022
• Supplement Dates FDA Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2021
• 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