MAUDE Adverse Event Report: EDWARDS LIFESCIENCE; SWAN GANZ CATHETER

Model Number 831F75-BASE NOT PACE VIP

Device Problems Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 06/11/2015

Event Type  Injury  

Event Description

Swan ganz catheter placed (b)(6) 2015.Catheter removed (b)(6) 2015, portion of the tip broke off.Sent patient to cardiac cath lab to remove foreign object.Tip inside arrow introducer.Biokit type: kit 2-11 1/4 x 6 3/4 x 9 3/8.Number on the return slip as printed: "(b)(4)".

• Brand Name: UNK
• Type of Device: SWAN GANZ CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCE; 1212 alton pkwy; irvine CA 92606
• MDR Report Key: 4875017
• MDR Text Key: 6259120
• Report Number: MW5043255
• Device Sequence Number: 1
• Product Code: DYG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/23/2015

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 Model Number: 831F75-BASE NOT PACE VIP
• Device Lot Number: ASKU BU: CC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/23/2015
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR