MAUDE Adverse Event Report: CORDIS CORPORATION OUTBACK; CATHETER FOR CROSSING TOTAL OCCLUSIONS

Model Number OTB59120A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/04/2018

Event Type  malfunction  

Event Description

It is a outback catheter, it is re-entry catheter that has a tip that comes out on the end of it with a needle.While md was using device the tip came off.He was able to retrieve it and no harm to patient.

• Brand Name: OUTBACK
• Type of Device: CATHETER FOR CROSSING TOTAL OCCLUSIONS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 n.w. 60th ave.; miami lakes FL 33014
• MDR Report Key: 7939438
• MDR Text Key: 123191072
• Report Number: 7939438
• Device Sequence Number: 0
• Product Code: PDU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OTB59120A
• Device Catalogue Number: OTB59120A
• Device Lot Number: 17668209
• 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: 08/07/2018
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/30/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20440 DA