MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC SWAN-GANZ CONTROLCATH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number C146F7

Device Problems Hole In Material (1293); Inflation Problem (1310)

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

Event Date 01/09/2017

Event Type  malfunction  

Event Description

During placement of a latex free swan-ganz catheter, the balloon would not inflate.Under magnification, a small hole was seen on the balloon.Manufacturer response for latex free swan-ganz catheter, swan-ganz controlcath thermodilution catheter.(per site reporter): the manufacturer was contacted.Currently waiting for a return call.The catheter will be saved to get some images under scanning electron microscope.

• Brand Name: SWAN-GANZ CONTROLCATH
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 6325326
• MDR Text Key: 67234677
• Report Number: 6325326
• Device Sequence Number: 1
• Product Code: DQO
• 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: Other
• Type of Report: Initial
• Report Date: 01/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: C146F7
• Device Catalogue Number: C146F7
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/17/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 01/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1