MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS LIFESCIENCES TRUWAVE; SWAN-GANZ CATHETER

Catalog Number PX2X2

Device Problems Break (1069); Material Protrusion/Extrusion (2979)

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

Event Date 01/09/2017

Event Type  Injury  

Event Description

Pulled out swan catheter per order, catheter came out easily without any resistance.At the end of the procedure when the catheter was almost out it snapped outside the pt and broke into two pieces with optic fiber exposed, held the remaining catheter, notified the ccm fellow and the attending immediately, ccm fellow pulled out rest of the catheter easily.Broken catheter saved for reference.Pt stable, vitals wnl.Stat chest x-ray ordered.No retained fragment seen.

• Brand Name: EDWARDS LIFESCIENCES TRUWAVE
• Type of Device: SWAN-GANZ CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES; irvine CA 92614
• MDR Report Key: 6242326
• MDR Text Key: 64681494
• Report Number: MW5067171
• Device Sequence Number: 1
• Product Code: DXO
• 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: 01/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/18/2018
• Device Catalogue Number: PX2X2
• Device Lot Number: 60429092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2017
• Is the Reporter a Health Professional?: Yes
• 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: 74 YR