MAUDE Adverse Event Report: EDWARDS LIFESCIENCES SMALL SIZE SINGALE STAGE VENOUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number TF010O90

Device Problem Collapse (1099)

Patient Problem No Code Available (3191)

Event Date 01/12/2017

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturer narrative: the device was not returned to edwards for evaluation.The reported clinical observation was unable to be confirmed.Manufacturing records were not reviewed as no lot number was provided.The instructions for use (ifu) was reviewed and no inadequacies were identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.The ifu provides the following indications for use: "venous return cannulae are intended for cannula drainage from the superior and inferior vena cava during extracorporeal circulation for a duration of < 6 hours.Venous return cannulae in sizes 6 fr.(2 mm) to 18 fr.(6 mm) can be used in pediatric patients." the ifu provides the following warnings and precautions: "when using small diameter cannulae, do not exceed the maximum pressure limit while increasing flow.A rapid pressure rise may result.Use the largest cannula possible, consistent with good surgical technique, to ensure adequate venous drainage.Line pressure exceeding acceptable clinical limits may result from incorrect catheter tip position and/or restricted tip patency.Confirm proper placement to minimize risk of injury.Securely tie-band the connector to cannula junction prior to initiating bypass to protect against tubing slippage.Wire-reinforced cannulae should be clamped in the non-reinforced section located at the connector end since clamping of the reinforced section may produce permanent cannula deformation, thereby impeding flow through the cannula and risking puncture or tearing of the cannula.Proper surgical procedures and techniques are the responsibility of the medical profession.Described procedures are provided for informational purposes only.Each physician must determine the appropriate use of this device for each patient based on medical training, experience, the type of procedure employed, and the benefits and risks associated with device use." a manufacturing deficiency was not identified.A definitive root cause cannot be determined at this time.No further corrective or preventative actions are required at this time.Trends will continue to be monitored through the use of edwards quality systems and if action is required, appropriate investigation will be performed.

Event Description

Edwards received information that during the use of a right angle tip venous cannula it was noticed that the patient was receiving a lot of volume.The cannula was warped to the point that the couldn't find the purse strings around the tip.This caused high volume being returned back to the patient.The device had been in use over 24 hours for ecmo.They were able to stabilize the venous perfusion and continued to use the cannula.The patient later expired due to reasons unrelated to the event involving the use of the cannula.The customer indicated to the edwards rep that they are aware of the 6 hour limitation for cannula usage.The size of the cannula used is unknown.Upon follow-up, the physician clarified that her concern was not that the cannula was defective, but she was looking for options that can be used for up to 10 days for infants that are requiring central ecmo.The physician said that the cannula collapses at the tip due to the fact that it is not wire-reinforced and that this happens often with ecmo cases.

• Brand Name: SMALL SIZE SINGALE STAGE VENOUS CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irivne CA 92614
• Manufacturer Contact: trushala nerurkar ; 1 edwards way; irvine, CA 92614 ; 9492501377
• MDR Report Key: 6304234
• MDR Text Key: 66680398
• Report Number: 3008500478-2017-00007
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120072
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TF010O90
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2017
• 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