MAUDE Adverse Event Report: COOK MEDICAL LLC FUSION OASIS STENT INTRODUCER; STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS

Catalog Number G31526

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/05/2023

Event Type  malfunction  

Event Description

Device piece (cook fusion oasis stent introducer) broke off and retained in patient during ercp procedure.

• Brand Name: FUSION OASIS STENT INTRODUCER
• Type of Device: STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS
• Manufacturer (Section D): COOK MEDICAL LLC
• MDR Report Key: 16953639
• MDR Text Key: 315546291
• Report Number: MW5117642
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/15/2023

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 Catalogue Number: G31526
• Device Lot Number: C1984789
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/17/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White