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 07/07/2022

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 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 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.

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 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 with evidence of full deployment.The device was returned without the over-sheath, only the blue grip was returned attached to the device.Microscopic examination was performed and it was found that the bushing had hit marks.Additionally, the bushing was deformed.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 one side of the hooks was found to be out of specification.No other problems with the device were noted.The reported event of clip could not detach from catheter was not confirmed.Investigation found that one side of the hooks was out of specification, this condition likely happened during or after the procedure, since this condition would have prevent the clip to be assembled in a first instance during the manufacturing process.It is possible that operational factors such as the technique used during removal of the clip, or the interaction between the yoke and the capsule, in order to deploy the clip could have caused the found problems of bushing deformed and hit marks on the bushing.However, the device was returned without the clip assembly and it is important to mention that the presence of this component is very important to the investigation in order to analyze any failure that could contribute with the problem faced by the physician.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: 15137702
• MDR Text Key: 296981538
• Report Number: 3005099803-2022-04088
• 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: 09/28/2022

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: 08/07/2022
• Device Model Number: M00522610
• Device Catalogue Number: 2261
• Device Lot Number: 0024317953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2022
• Initial Date FDA Received: 08/01/2022
• Supplement Dates Manufacturer Received: 08/30/2022
• Supplement Dates FDA Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2019
• 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: 49 YR
• Patient Sex: Male
• Patient Weight: 70 KG