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

Model Number PIKV

Device Problem Mechanical Problem (1384)

Patient Problem Vascular System (Circulation), Impaired (2572)

Event Date 05/06/2014

Event Type  No Answer Provided  

Event Description

As reported by our european colleagues, a pikv guidewire kit was found kinked and coiled itself on guide.The abnormality was observed after the guide was mounted in the jugular, superior vena cava to the right atrium.The guide was previously purged as recommended and did not show any abnormality before use in patient.The guide and cannula were used.The consequences of the defective guide on the patient were as noticed a wound of the superior vena cava (svc) resulting in an emergency clamping upstream and downstream of the svc and therefore a fall/lower level of the flow of the cec (which is never good for the patient).The conditions of the storage and use were as usual.

Manufacturer Narrative

This device has been received and is currently under evaluation into root cause.

Manufacturer Narrative

As reported a pikv was found kinked and coiled itself on guide.The abnormality was observed after the guide was mounted in the jugular, superior vena cava to the right atrium.The guide was previously purged as recommended and did not show any abnormality before use in patient.The guide and cannula were used.The consequences of the defective guide on the patient were as noticed a wound of the superior vena cava (svc) resulting in an emergency clamping upstream and downstream of the svc and therefore a fall/lower level of the flow of the cec (which is never good for the patient).The conditions of the storage and use were as usual.The hospital want a response in < 2 months.Evaluation: visual inspection of the returned guidewire found many spirals through the device.There was a kink found approximately at the 85cm distal end with some fibers in between the coils.A wire was found protruding out of the proximal end of the guidewire.The complaint was confirmed but the root cause is unable to be determined from available information.Trends for this issue are in control and will continue to be monitored.Manufacturing records were reviewed and there were no related product non conformances found.There will be no pra or capa initiated at this time.The instructions for use, training, and risk control measures are appropriate at this time.Trends will continue to be monitored on through the edwards quality system.

• Brand Name: GUIDEWIRE
• 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: walter wiegand ; 12050 lone peak parkway; draper, UT 84020 ; 8015655200
• MDR Report Key: 3835607
• MDR Text Key: 4501972
• Report Number: 3008500478-2014-00071
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K123298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PIKV
• Device Lot Number: 59640083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/06/2014
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/06/2014
• Initial Date Manufacturer Received: 08/05/2014
• Initial Date FDA Received: 05/28/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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