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 01/24/2022

Event Type  malfunction  

Manufacturer Narrative

Medical device problem code: (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 stomach 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.The procedure was completed with another resolution clip device.There were no patient complications reported as a result of this event.The patient 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 stomach 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.The procedure was completed with another resolution clip device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

H6: medical device problem code a15 captures the reportable event of clip unable to release from catheter.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 to the catheter, the clip assembly was returned activated inside the outer-sheath.It was also observed that the catheter was kinked.Microscopic examination was performed and it was found that the device had evidence of premature deployment and the clip had the first activation performed.The clip arms were misaligned.Dimensional analysis was performed on the bushing outer diameter, and it was found to be within specification.A dimensional analysis was also performed between the hooks of the bushing and the pin gage, and both were within specification.No other problems with the device were noted.Based on the condition of the returned device, the reported event of clip unable to release from the catheter was not confirmed as the device returned deployed inside the outer sheath.Investigation found that the clip arms were misaligned, this is likely due to operational factors such as the amount of tissue grasped during the procedure.The catheter kinked is likely to happened due to operational factors such as the technique used by the physician during insertion or removal of the device from the scope.Regarding the evidence of premature deployment, this failure is likely due to operational factors during the procedure such as trying to open the clip once it was already activated.The returned device review showed no evidence of either the alleged(s) or any defect which could have contributed to the event.Therefore, the most probable root cause for this complaint is no problem detected.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: 13825256
• MDR Text Key: 288107750
• Report Number: 3005099803-2022-01438
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/21/2022

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 Model Number: M00522610
• Device Catalogue Number: 2261
• Device Lot Number: 0027674414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2022
• Initial Date FDA Received: 03/19/2022
• Supplement Dates Manufacturer Received: 03/24/2022
• Supplement Dates FDA Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2021
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 62 KG