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

Model Number	M00522600
Medical Device Problem Codes	Use of Device Problem (1670); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Imdrf device code a15 captures the reportable event of clip could not be deployed.
Event or Problem Description
It was reported to boston scientific corporation that a resolution clip device was used in the esophagus during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2023.During the procedure, the clip could not be deployed.It was reported that the device was removed, and the procedure was completed with another resolution clip.Note: it was reported that the customer attempted to remove the sheath completely off the device.However, per the instructions for use, 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.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a15 captures the reportable event of clip could not be deployed.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 stuck into the bushing.The device was returned without the over-sheath.Microscopic examination was performed, and it was found that the clip assembly bottom part was deformed.Functional evaluation was performed, and it was found that the handle does not have communication with the clip assembly.No other problems with the device were noted.The reported event of clip could not be deployed was confirmed.It is possible that the amount of tissue grasped was bigger than the clip could close, causing the customer needed to apply an excessive force to close the clip arms in order to activate them.However, due to the amount of tissue grasped, this force was enough to detach the clip from the bushing, but it was not enough to activate them.Subsequently, due to this detachment, when the customer attempted to reposition the clip into the bushing, the clip got incorrectly positioned.Additionally, it is most likely that the physician kept pulling back the clip which cause the control wire and clip detachment, causing a deployment problem.Regarding the found problem of clip assembly deformed, this is likely due to the entrapment against the bushing.Taking all available information into consideration, the most probable cause of this complaint is adverse event related to procedure because the adverse event occurred during the procedure and the device had no influence on the event.A product labeling review identified that the device was not used per the instructions for use (ifu)/product label as it was reported that the over-sheath was attempted to be completely removed from the device which is not describe in the instructions for use.
Event or Problem Description
It was reported to boston scientific corporation that a resolution clip device was used in the esophagus during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2023.During the procedure, the clip could not be deployed.It was reported that the device was removed, and the procedure was completed with another resolution clip.Note: it was reported that the customer attempted to remove the sheath completely off the device.However, per the instructions for use, 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.The patient's condition at the conclusion of the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation that a resolution clip device was used in the esophagus during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2023.During the procedure, the clip could not be deployed.It was reported that the device was removed, and the procedure was completed with another resolution clip.Note: it was reported that the customer attempted to remove the sheath completely off the device.However, per the instructions for use, 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.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a15 captures the reportable event of clip could not be deployed.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 stuck into the bushing.The device was returned without the over-sheath.Microscopic examination was performed, and it was found that the clip assembly bottom part was deformed.Functional evaluation was performed, and it was found that the handle does not have communication with the clip assembly.No other problems with the device were noted.The reported event of clip could not be deployed was confirmed.It is possible that the amount of tissue grasped was bigger than the clip could close, causing the customer needed to apply an excessive force to close the clip arms in order to activate them.However, due to the amount of tissue grasped, this force was enough to detach the clip from the bushing, but it was not enough to activate them.Subsequently, due to this detachment, when the customer attempted to reposition the clip into the bushing, the clip got incorrectly positioned.Additionally, it is most likely that the physician kept pulling back the clip which cause the control wire and clip detachment, causing a deployment problem.Regarding the found problem of clip assembly deformed, this is likely due to the entrapment against the bushing.Taking all available information into consideration, the most probable cause of this complaint is adverse event related to procedure because the adverse event occurred during the procedure and the device had no influence on the event.A product labeling review identified that the device was not used per the instructions for use (ifu)/product label as it was reported that the over-sheath was attempted to be completely removed from the device which is not describe in the instructions for use.

• Brand Name: RESOLUTION CLIP
• Common Device Name: 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: 16600900
• Report Number: 3005099803-2023-01364
• Device Sequence Number: 6193890
• Product Code: PKL
• UDI-Device Identifier: 08714729504764
• UDI-Public: 08714729504764
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K222503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/08/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/04/2024
• Device Model Number: M00522600
• Device Catalogue Number: 2260
• Device Lot Number: 0028054270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2023
• Supplement Date Received by Manufacturer: 04/18/2023; 05/19/2023
• Initial Report FDA Received Date: 03/23/2023
• Supplement Report FDA Received Date: 05/12/2023; 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 60 KG