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

Model Number M00522612

Device Problems Use of Device Problem (1670); Failure to Advance (2524); Activation, Positioning or Separation Problem (2906)

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

Event Date 08/03/2022

Event Type  malfunction  

Manufacturer Narrative

Medical device code (b)(4).Investigation results: the returned resolution clip device was analyzed, and a visual evaluation noted that the device was returned with the clip assembly stuck into the bushing.The over-sheath was returned attached to the catheter.Microscopic examination was performed, and it was found that the capsule bottom part was damaged.Additionally, the clip had both activations performed as the yoke was detached from the control wire.Functional evaluation performed revealed that the clip had no communication with the handle.No other problems with the device were noted.A photo of the device pouch with label was reviewed and no problems were noted with the pouch.The reported event of clip unable to advance out of the sheath was not confirmed.It is possible that operational factors, such as activating the clip assembly and then trying to open the clip after the first activation, could have caused a clip soft deployment.Subsequently, when the customer pulled back the handle for closing the arms again, this action induced that the capsule got localized incorrectly on the bushing; therefore, causing that the capsule and the bushing got stuck.Additionally, while the physician kept pulling back the handle in order to release the clip assembly, this technique generated that the yoke got detached from the control wire, causing the entrapment of the clip assembly into the busing and contributed to the deformation found on the clip assembly.The investigation findings and all information available do not lead to a clear conclusion about the cause of the reported adverse event.Therefore, the most probable root cause is cause not established.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A product labeling review identified that the device was not used per the instructions for use (ifu)/product label as the over-sheath was attempted to be completely removed prior to the procedure which is not describe in the instructions for use.

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, the clip was unable to advance out of the sheath.The procedure was completed with a different device.Note: it was reported that the customer attempted to remove the sheath completely off the device.However, per the hemostasis clip instructions for use (ifu), the over sheath is supposed to be retracted to expose the clip and not removed from the catheter.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation finding of clip assembly stuck into the bushing.

• 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: 15700844
• MDR Text Key: 306884080
• Report Number: 3005099803-2022-06256
• 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: Physician
• Type of Report: Initial
• Report Date: 10/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2022
• 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: 0029324957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2022
• 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