MAUDE Adverse Event Report: EDWARDS LIFESCIENCES TECHNOLOGY SARL SWAN GANZ; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Lot Number 61352638

Device Problem Difficult to Advance (2920)

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

Event Date 12/04/2018

Event Type  malfunction  

Event Description

While using the swan ganz to do a right heart catheter procedure, the port was flushed and it did have some resistance but it did flush.While trying to advance the catheter into the vein it would not advance or cross past the hub.The catheter was flushed again and used a.025 wire to try to advance, but still wouldn't pass the dual lumen port.So, a new one was used and worked fine.

• Brand Name: SWAN GANZ
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES TECHNOLOGY SARL; one edwards way; irvine CA 92614
• MDR Report Key: 8189271
• MDR Text Key: 131167479
• Report Number: 8189271
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/07/2018,12/05/2018

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 Lot Number: 61352638
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/07/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/21/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1