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

Model Number M00521231

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/07/2021

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 medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a resolution 360 clip device was unpacked on (b)(6) 2021.It was reported that the packaging pouch was taken straight out of the box; however, the nurse observed that there were brown stains on the packaging of the clips.It is as if the clip wrap had been indirectly installed, either at the factory or in another location.There was no patient or procedure involved in this event.

Event Description

It was reported to boston scientific corporation that a resolution 360 clip device was unpacked on (b)(6) 2021.It was reported that the packaging pouch was taken straight out of the box.However, the nurse observed that there were brown stains on the packaging of the clips.It is as if the clip wrap had been indirectly installed, either at the factory or in another location.There was no patient or procedure involved in this event.

Manufacturer Narrative

H6: medical device code a180104 captures the reportable issue of foreign material on the packaging pouch.H10: investigation results: the resolution 360 clip device was returned and technical analysis was completed.Analysis of the returned product revealed that the device was returned inside the pouch and the brown strain was found on the pouch.Further testing was performed and according to the blood detection test, the pouch could have had contact with drops of blood in the medical center, hence, the theory can be confirmed due to presumptive blood detection test was performed and the result was positive for blood.The reported event was confirmed.This issue is likely traced to the inappropriate transport or storage of the device.Therefore, the most probable root cause is cause traced to transport/storage.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A review of the instructions for use (ifu) and product labeling was completed and did not reveal any evidence of device misuse or that the device was used in a manner inconsistent with the labeled indications.

• Brand Name: RESOLUTION 360 CLIP
• Type of Device: HEMOSTATIC METAL CLIP FOR THE GI TRACT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11940825
• MDR Text Key: 254335270
• Report Number: 3005099803-2021-02669
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 08714729875635
• UDI-Public: 08714729875635
• Combination Product (y/n): N
• PMA/PMN Number: K151802
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/18/2023
• Device Model Number: M00521231
• Device Catalogue Number: 54773
• Device Lot Number: 0026290202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Date Manufacturer Received: 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1