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

Model Number TD 131F7

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Date 04/03/2018

Event Type  malfunction  

Event Description

Defective swan-ganz catheter.Upon inspecting the device before insertion, the device was found to have what appears to be a tear along the sheath.It was never used on patient.

• Brand Name: SWAN-GANZ CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 7595753
• MDR Text Key: 110874903
• Report Number: 7595753
• 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: 05/15/2018,05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: TD 131F7
• Device Catalogue Number: 131F7P
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/15/2018
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/15/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/13/2018
• 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
• Patient Age: 78 YR