MAUDE Adverse Event Report: EDWARDS EDWARDS SWAN GANZ BIPOLAR PACING; TRANSVENOUS PACING WIRE

Model Number F\D97120F5

Device Problems Break (1069); Detachment Of Device Component (1104); Sticking (1597)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

While removing a patient's tvp (transvenous pacing wire) from the introducer catheter, the tip of the tvp got stuck in and broke off inside of the introducer catheter.After removing the introducer catheter, the tip of the tvp was recovered from the hub of the introducer.

• Brand Name: EDWARDS SWAN GANZ BIPOLAR PACING
• Type of Device: TRANSVENOUS PACING WIRE
• Manufacturer (Section D): EDWARDS; irvine CA 92614
• MDR Report Key: 7376905
• MDR Text Key: 103827910
• Report Number: MW5076187
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: F\D97120F5
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 56 YR