MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESOLUTION 360 CLIP; HEMOSTATIC METAL CLIP FOR THE GI TRACT

Model Number	M00521241
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event was approximated to (b)(6) 2020 as the event date is unknown.(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 or Problem Description
It was reported to boston scientific corporation that a resolution 360 clip device was used in the stomach during a gastroscopy procedure performed on an unknown date.According to the complainant, during the procedure, the clip was fired; however, the clip did not work.The procedure was completed with another resolution 360 clip device.There have been no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Additional Manufacturer Narrative
Block b3: date of event was approximated to (b)(6) 2020 as the event date is unknown.Block h6: device code 2906 captures the reportable event of when firing the clip did not work.Block h10: investigation results the returned resolution 360 clip device was analyzed, and a visual evaluation noted that the clip assembly was not returned with the device.It was possible to observe that the control wire was kinked.The handle was disassembled for further analysis and no other issues with the device were 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 or Problem Description
It was reported to boston scientific corporation that a resolution 360 clip device was used in the stomach during a gastroscopy procedure performed on an unknown date.According to the complainant, during the procedure, the clip was fired; however, the clip did not work.The procedure was completed with another resolution 360 clip device.There have been no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• Brand Name: RESOLUTION 360 CLIP
• Common Device Name: HEMOSTATIC METAL CLIP FOR THE GI TRACT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9793902
• Report Number: 3005099803-2020-00732
• Device Sequence Number: 16787598
• Product Code: PKL
• UDI-Device Identifier: 08714729875673
• UDI-Public: 08714729875673
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K151802
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/04/2021
• Device Model Number: M00521241
• Device Catalogue Number: 54773
• Device Lot Number: 0023108289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2020
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 03/15/2020
• Initial Report FDA Received Date: 03/05/2020
• Supplement Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1