MAUDE Adverse Event Report: ALCYONE LIFESCIENCES AMC SILICONE CATHETER; CANNULA, VENTRICULAR

Model Number A0001

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/08/2017

Event Type  malfunction  

Event Description

During the injection of oncolytic viral dna agents, the silicone catheter tip was damaged while inside the patient.The entire catheter was not able to be successfully removed so a small piece was retained.Dr.Communicated with the vendor rep to find out if the material would be harmful to the patient.He confirmed that it would not be unsafe to leave the piece inside the patient.

• Brand Name: AMC SILICONE CATHETER
• Type of Device: CANNULA, VENTRICULAR
• Manufacturer (Section D): ALCYONE LIFESCIENCES; 116 john street; suite 300; lowell MA 01852
• MDR Report Key: 9255510
• MDR Text Key: 164282375
• Report Number: 9255510
• Device Sequence Number: 1
• Product Code: HCD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/09/2019,10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A0001
• Device Catalogue Number: A0001
• Device Lot Number: 14309294
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/09/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22995 DA