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

Model Number M00522610

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 06/10/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.

Event Description

It was reported to boston scientific corporation that a resolution clip device was used in the colon during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2022.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 despite repeatedly pulling and pushing the handle.Ultimately, the tip of the clip fell off after it was forcefully pulled out of the patient.The procedure was completed with another resolution 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.

Manufacturer Narrative

Block h6: medical device problem code a15 captures the reportable event of clip unable to release from the catheter.Block h10: investigation results the returned resolution clip device was analyzed, and a visual evaluation noted that the device was returned without the clip assembly attached.The clip assembly was returned in a separate bag.The device was returned without the over-sheath.Additionally, the clip assembly had one arm bent.Microscopic examination was performed, and it was found that the clip had one arm activated.No other problems with the device were noted.The reported event of clip clip unable to release from the catheter was not confirmed.It is possible that the device manipulation during the procedure, such as a high axial asymmetric load applied to only one clip arm could have caused the found problem of clip arm bent.Additionally, it is likely that the customer tried to grasp a large amount of tissue which can cause a deformation in the distal section of the clip arm, affecting the capability of the jaws of the clip to close correctly.Moreover, it is important to mention that according to the instructions for use (ifu), "applying tangential pressure to an opened or closed clip may result in the clip separating from the catheter and potentially kinking or damaging the device".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 review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and from the information available, this device was not used per the instructions for use (ifu)/product label as it was reported that the clip was forcefully pulled out of the patient 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 in the colon during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2022.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 despite repeatedly pulling and pushing the handle.Ultimately, the tip of the clip fell off after it was forcefully pulled out of the patient.The procedure was completed with another resolution 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.

• 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: 14914145
• MDR Text Key: 295254605
• Report Number: 3005099803-2022-03508
• Device Sequence Number: 1
• Product Code: MCH
• UDI-Device Identifier: 08714729504795
• UDI-Public: 08714729504795
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K040148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/20/2022

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 Expiration Date: 02/28/2024
• Device Model Number: M00522610
• Device Catalogue Number: 2261
• Device Lot Number: 0026975777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/10/2022
• Initial Date FDA Received: 07/05/2022
• Supplement Dates Manufacturer Received: 08/22/2022
• Supplement Dates FDA Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2021
• 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
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 70 KG