MAUDE Adverse Event Report: ANGIODYNAMICS, INC. ANGIODYNAMICS / ANGIOVAC; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Catalog Number 25186

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/05/2019

Event Type  malfunction  

Event Description

Cannula not smooth/defective.Cannula was placed over the amplatz super stiff wire, but it would not cross the tricuspid valve.Required replacement by similar device.Cath procedure proceeded without issue.Sales rep in room.

• Brand Name: ANGIODYNAMICS / ANGIOVAC
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): ANGIODYNAMICS, INC.; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 9122864
• MDR Text Key: 160191681
• Report Number: 9122864
• Device Sequence Number: 1
• Product Code: DWF
• 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: 08/30/2019

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: No Information
• Device Catalogue Number: 25186
• Device Lot Number: 5464672
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/30/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/26/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 12045 DA
• Patient Weight: 90