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 02/15/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter facility address: (b)(6).(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, 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 and inside the patient, the clip was able to grasp and lock onto tissue; however, the clip was unable to release from the catheter to deploy.The procedure was completed with the 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.

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 february 15, 2022.During the procedure and inside the patient, the clip was able to grasp and lock onto tissue; however, the clip was unable to release from the catheter to deploy.The procedure was completed with the 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 e1: initial reporter facility address: (b)(6).Block h6: medical device problem code a15 captures the reportable event of clip failed to release from 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 and with evidence of full deployment.The clip assembly was returned in a separate bag.Additionally, the device was returned without the over-sheath.Microscopic examination was performed and it was found that the clip assembly had evidence of proper deployment as both activations were performed.The bushing had hit marks on one hook.No other problems with the device were noted.The reported event of clip unable to release from the catheter was not confirmed.Investigation found that the clip assembly was returned in a separate bag and with both activations performed which is an evidence that the clip did deploy.Regarding the hit marks found on one hook of the bushing, this is likely due to the interaction between the yoke and the capsule, in order to deploy the clip.However, there is not enough information, objective evidence, or descriptive conditions to understand what could have caused the reported event.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.

• 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: 14207923
• MDR Text Key: 290071815
• Report Number: 3005099803-2022-02228
• 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: 08/09/2022

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: 06/18/2022
• Device Model Number: M00522610
• Device Catalogue Number: 2261
• Device Lot Number: 0024058673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2022
• Initial Date FDA Received: 04/26/2022
• Supplement Dates Manufacturer Received: 07/15/2022
• Supplement Dates FDA Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/04/2019
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 40 KG