MAUDE Adverse Event Report: INTEGRA LIFE SCIENCES CATH VENTRICULAR CORDIS; VENTRICULAR CATHETER

Model Number 901302

Device Problems Break (1069); Material Separation (1562); Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/30/2019

Event Type  Injury  

Event Description

Icp monitor catheter tip broke off during removal.Return to operating room on (b)(6) 2019 with retained tip extracted.

• Brand Name: CATH VENTRICULAR CORDIS
• Type of Device: VENTRICULAR CATHETER
• Manufacturer (Section D): INTEGRA LIFE SCIENCES ; 1100 campus rd; princeton NJ 80540
• MDR Report Key: 9593208
• MDR Text Key: 175376765
• Report Number: 9593208
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/07/2020,01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 901302
• Device Catalogue Number: 901302
• Device Lot Number: 901-902
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/07/2020
• Distributor Facility Aware Date: 12/30/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/09/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR