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

Model Number M00522612

Device Problems Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/20/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a resolution clip device was used during a procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the clip did not deploy correctly.Additionally, a piece of the device broke off and was retrieved by the physician.No patient complications have been reported due to this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Manufacturer Narrative

Block h6: device code 2906 captures the reportable event of clip did not deploy correctly.Block h10: investigation results the returned resolution clip device was analyzed, and a visual evaluation noted that the clip assembly was returned with one clip arm broken.Additionally, the broken section of the clip arm showed evidence of corrosion.Functional evaluation was performed using a tortuous fixture, and the clip released from the catheter successfully.It was also noted that the yoke and or ball weld had no issues noted.The reported event was not confirmed.This failure is likely due to problems traced to manufacturing process.Therefore, the most probable root cause is manufacturing deficiency.An investigation is in place to address this issue.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu)/product label.

Event Description

It was reported to boston scientific corporation that a resolution clip device was used during a procedure performed on (b)(6), 2020.According to the complainant, during the procedure, the clip did not deploy correctly.Additionally, a piece of the device broke off and was retrieved by the physician.No patient complications have been reported due to this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• Brand Name: RESOLUTION CLIP CLIPPING DEVICE
• Type of Device: CLIP, HEMOSTATIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10114880
• MDR Text Key: 193705071
• Report Number: 3005099803-2020-02121
• Device Sequence Number: 1
• Product Code: MCH
• UDI-Device Identifier: 08714729504818
• UDI-Public: 08714729504818
• Combination Product (y/n): N
• PMA/PMN Number: K040148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/27/2022
• Device Model Number: M00522612
• Device Catalogue Number: 2261
• Device Lot Number: 0024243636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2020
• Date Manufacturer Received: 06/29/2020
• Patient Sequence Number: 1