MAUDE Adverse Event Report: COOK MEDICAL CENTIMETER SIZING CATHETER

Model Number G31215

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Claudication (2550); Foreign Body In Patient (2687)

Event Date 09/16/2014

Event Type  Injury  

Event Description

A (b)(6) male with history of abdominal aortic aneurysm (aaa) had an outpatient stress test showing inferior ischemia.On (b)(6) 2014, he came to our hospital for a cardiac catherization with possible pci as well as an endovascular aortic repair of the aaa.He underwent the cardiac cath, was found to have critical disease in the distal right coronary artery and a drug eluting stent was placed.Immediately following that, he underwent the aaa repair.Procedures were completed without any significant issues and patient recovery was unremarkable.Patient developed severe claudication in lower left leg and angiogram in early november showed femoral occlusion.Patient was admitted on (b)(6) 2014 to have the l femoral endarterectomy and patch angioplasty.During this procedure, the surgeon found an item (foreign body) in the left femoral artery that looked possibly like a piece of catheter from a previous intervention.The item was removed and has been evaluated for identification.The removed foreign body (fb) was examined by the pathologist and released ro risk management.The surgeons, the radiology techs and nurses, the endologix rep and the cook medical rep have all visually examined the fb.The rca team concluded that the fb was the "peel away" component of the cook centimeter sizing catheter used during the aaa repair on (b)(6)2014.The item is not separately counted and is not radiopaque.It functions as a straightener for the pigtail tip of the sizing catheter.Once it straightens the tip of the catheter, it should be peled apart and taken off the catheter.Alternatively, if it is not used to straighten the pigtail cath tip, it can remain at the far end of the catheter, away from the tip going into the body.

• Brand Name: CENTIMETER SIZING CATHETER
• Type of Device: CENTIMETER SIZING CATHETER
• Manufacturer (Section D): COOK MEDICAL; bloomington 47402
• MDR Report Key: 4375313
• MDR Text Key: 5117625
• Report Number: MW5039837
• Device Sequence Number: 1
• Product Code: DQO
• 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: 12/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: G31215
• Device Catalogue Number: MR5.0-35-70-P-10S-PIC-CSC-20
• Device Lot Number: 5184583
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/23/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ENDOLOGIX BIFURCATED STENT GRAFT
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 92