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

Model Number M00521400

Device Problems Break (1069); Mechanical Problem (1384)

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

Event Date 02/03/2023

Event Type  malfunction  

Event Description

While clip was in patient's colon, clip failed to close and broke off in the patient's colon.

• Brand Name: RESOLUTION 360 ULTRA CLIP
• Type of Device: HEMOSTATIC METAL CLIP FOR THE GI TRACT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; marlborough MA 01752
• MDR Report Key: 16461874
• MDR Text Key: 310624390
• Report Number: MW5115335
• Device Sequence Number: 1
• Product Code: PKL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: M00521400
• Device Catalogue Number: M00521400
• Device Lot Number: 30629451
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White