MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESOLUTION 360 CLIP; HEMOSTATIC METAL CLIP FOR THE GI TRACT

Model Number M00521232

Device Problems Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/13/2023

Event Type  malfunction  

Manufacturer Narrative

Imdrf device code a15 captures the reportable event of clip would not release.

Event Description

It was reported to boston scientific corporation that a resolution 360 clip device was used in the mucosa during an unknown procedure performed on (b)(6) 2023.During the procedure, the clip was deployed however, it would not release from catheter.They tried all sorts of maneuvers to get the clip to release.The device had to be tugged off and when pulled out the clip was still attached to it.The procedure was completed with another resolution 360 clip device.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 Description

It was reported to boston scientific corporation that a resolution 360 clip device was used in the mucosa during procedure performed on (b)(6) 2023.During the procedure, the clip was deployed however, it would not release.The clip was tried all sorts, scope position, spraying water, change of position trying to release but it was stuck.The device had to tug it off and when pulled out the clip was still attached to it.The procedure was completed with another resolution 360 clip device.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.No further information has been obtained despite good faith efforts.

Manufacturer Narrative

Block h6: imdrf device code a15 captures the reportable event of clip would not release.Block h6: imdrf patient code e2015 captures the reportable event of mucosal injury.

Event Description

It was reported to boston scientific corporation that a resolution 360 clip device was used in the mucosa during procedure performed on (b)(6) 2023.During the procedure, the clip was deployed however, it would not release.The clip was tried all sorts, scope position, spraying water, change of position trying to release but it was stuck.The device had to tug it off and when pulled out the clip was still attached to it.The procedure was completed with another resolution 360 clip device.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.No further information has been obtained despite good faith efforts.***correction**** during the procedure, the clip was deployed; however, the clip would not release from the catheter.They tried all sorts of maneuvers to get the clip to release but the clip was stuck.The clip had to be tugged off the mucosa which caused a mucosal injury to the patient, requiring further clipping.The procedure was completed with another resolution 360 clip.

Manufacturer Narrative

Block h6: imdrf device code a15 captures the reportable event of clip would not release.Block h11: correction: b5 (describe event or problem), e1(initial reporter phone), h6 (patient codes).

Manufacturer Narrative

Block h6: imdrf device code a15 captures the reportable event of clip would not release.Investigation results: the returned resolution 360 clip device was analyzed, and a visual evaluation noted that the device was returned with the clip assembly stuck into the bushing.Microscopic examination was performed, and it was found that the clip assembly bottom part was deformed.Functional evaluation was performed, and it was observed that the handle does not have communication with the clip assembly.No other problems with the device were noted.With all the available information, boston scientific corporation concludes that the reported event of clip would not release from catheter 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 this detachment, when the customer attempted to reposition the clip into the bushing, the clip got incorrectly positioned, and most likely the physician kept pulling back the clip, causing the control wire and clip detachment, resulting to a deployment problem.Regarding the clip assembly being deformed, it is likely due to the entrapment against the bushing.The tissue damage is most likely due to the adversities faced by the physician with the device, the tissue damage was a consequence of this previous event.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 labeling review was performed and from the information available, this device was used per the instructions for use (ifu)/product label.

Event Description

It was reported to boston scientific corporation that a resolution 360 clip device was used in the mucosa during a clipping procedure performed on (b)(6) 2023.During the procedure, the clip was deployed; however, the clip would not release from the catheter.They tried all sorts of maneuvers to get the clip to release but the clip was stuck.The clip had to be tugged off the mucosa which caused a mucosal injury to the patient, requiring further clipping.The procedure was completed with another resolution 360 clip.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.

• Brand Name: RESOLUTION 360 CLIP
• Type of Device: HEMOSTATIC METAL CLIP FOR THE GI TRACT
• 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: 16681310
• MDR Text Key: 312778626
• Report Number: 3005099803-2023-01698
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 08714729875642
• UDI-Public: 08714729875642
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K222503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/17/2023

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
• Device Operator: Health Professional
• Device Model Number: M00521232
• Device Catalogue Number: 54774
• Device Lot Number: 0030316073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/13/2023
• Initial Date FDA Received: 04/05/2023
• Supplement Dates Manufacturer Received: 04/07/2023; 05/08/2023; 06/22/2023
• Supplement Dates FDA Received: 05/01/2023; 05/08/2023; 07/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2022
• 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