MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC SWAN-GANZ; CATHETER, FLOW DIRECTED

Model Number D97130F5

Device Problems Material Disintegration (1177); Difficult to Remove (1528); Component Missing (2306); Material Protrusion/Extrusion (2979); Physical Resistance/Sticking (4012)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/06/2018

Event Type  malfunction  

Event Description

An elderly female with severe aortic stenosis had a transcatheter aortic valve replacement (tavr) procedure with insertion of temporary transvenous pacer (ttvp) in left femoral site that was maintained on operative night secondary to heart block and bradycardia.The next day, when ttvp was removed by aprn, balloon and was deflated and resistance was met.White luer cap was not loosened prior to removal.An empty syringe was attached to the sheath to cause negative pressure and the catheter was then able to be removed.Upon inspection, catheter tip shredded, wires exposed and balloon tip missing.Doctor at bedside and aspirated sheath.Blood clot/balloon recovered and set with rep.The lot number listed was the lot number of other devices on the shelf.As we did not know the lot number of the catheter for certain, we removed all of the catheters we had to replace with new lot numbers a few days later.Lot numbers removed were: 61516343,61435187, 61415902, 60844481, 61435187.

• Brand Name: SWAN-GANZ
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 8193682
• MDR Text Key: 131308277
• Report Number: 8193682
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: D97130F5
• Device Catalogue Number: D97130F5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/20/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24090 DA
• Patient Weight: 143