MAUDE Adverse Event Report: EDWARDS LIFESCIENCES ENDOVENT PULMONARY CATHETER; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number EV

Device Problem Bent (1059)

Patient Problem Cardiac Perforation (2513)

Event Date 04/28/2014

Event Type  Injury  

Event Description

As reported by our colleagues in europe: the patient was a (b)(6) year-old female with aortic stenosis, good lv function.Past history of hypertension and hypercholesterolemia and operation was mini-avr (rat).Induction of anaesthesia was uneventful.No problem with insertion of proplege (coronary sinus catheter).Endovent (pulmonary catheter) was inserted with pressure monitoring and took a few attempts to successfully position.On opening the pericardium, the surgeon found blood (dark - venous) and procedure was converted to open avr.This decision was made as he was unsure where the venous blood was coming from, initial thought was maybe from the coronary sinus.After opening a small hole was seen in the lateral wall of the right ventricle but it had closed itself.No intervention was needed.The patient was not harmed.Rest of the intra-op and post-op course was uneventful.The endovent device was removed and pictures were taken which will be attached to this complaint.There is a kink in the catheter which was probably the cause of the perforation.

Manufacturer Narrative

Evaluation into root cause is currently underway.

Manufacturer Narrative

The complaint device was not returned to edwards for evaluation as it was discarded by the facility.The customer stated the device was inspected prior to use and no issues were noted; the device looked fine.In addition, the lot number for the device was not available, therefore, a device history record (dhr) review of the affected device could not be performed.Per the ifu, cardiovascular injury, such as perforation or damage (dissection) of vessels, ventricle and atrium, are known potential complication associated with the use of the endovent pulmonary catheter.The device ifu also warns that if resistance is felt when removing the endovent pulmonary catheter through the catheter introducer sheath, do not exert excessive force.Verify that the balloon is fully deflated and the stopcock is closed.If necessary, position the fluoroscope over the heart, and then remove the endovent pulmonary catheter and catheter introducer sheath as a unit to prevent damage to the endovent pulmonary catheter or injury to the patient.In this case, the exact cause of the ventricular perforation cannot be confirmed.The available information suggests, patient and procedural factors [diseased, thin-walled ventricle and excessive force during use of the device] may have possibly contributed to the event.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.A review of the complaint database indicates this is the only complaint of ventricular perforation for this device.Trends will continue to be monitored.No corrective or preventative actions are required.

• Brand Name: ENDOVENT PULMONARY CATHETER
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 12050 lone peak parkway; draper UT 84020
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 12050 lone peak parkway; draper UT 84020
• Manufacturer Contact: walt wiegand ; 12050 lone peak parkway; draper, UT 84020 ; 8015655200
• MDR Report Key: 3929781
• MDR Text Key: 4537058
• Report Number: 3008500478-2014-00101
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K981009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/18/2014

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?: Yes
• Device Operator: Health Professional
• Device Model Number: EV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/28/2014
• Event Location: Hospital
• Date Report to Manufacturer: 06/18/2014
• Initial Date Manufacturer Received: 06/18/2014
• Initial Date FDA Received: 07/11/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/15/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR