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 08/17/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to boston scientific corporation that a resolution clip device was used in the intestinal tract during an endoscopic mucosal resection (emr) procedure performed on (b)(6) 2022.During the procedure, the clip was able to grasp and lock onto tissue; however, the clip could not detach 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's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block h6: medical device code a15 captures the reportable event of clip could not detach 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 and the device had evidence of full deployment.The device was returned without the over-sheath.Microscopic examination was performed and no failures were found on the bushing.Dimensional examination 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 both sides were noted to be within specification.No problems with the device were noted.The reported event of clip could not be detached from catheter was not confirmed.Investigation found that the device returned without the clip assembly and with evidence of full deployment.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.

Event Description

It was reported to boston scientific corporation that a resolution clip device was used in the intestinal tract during an endoscopic mucosal resection (emr) procedure performed on (b)(6) 2022.During the procedure, the clip was able to grasp and lock onto tissue; however, the clip could not detach 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'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: 15427204
• MDR Text Key: 302292172
• Report Number: 3005099803-2022-05162
• 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: 11/10/2022

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: 0028620162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2022
• Initial Date FDA Received: 09/15/2022
• Supplement Dates Manufacturer Received: 10/24/2022
• Supplement Dates FDA Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2022
• 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
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 48 KG