MAUDE Adverse Event Report: ESTECH RAP FEMORAL VENOUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Catalog Number 200-150

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Fever (1858); Unspecified Infection (1930); Skin Discoloration (2074)

Event Date 10/05/2014

Event Type  malfunction  

Event Description

Patient is a man on the cardiac surgical service who underwent redo mitral valve replacement approximately 3 months ago, and who had a cardiac catheterization through the right groin 2 days prior.On the day of consultation, the evening approximately 10 days post mitral valve replacement, he was noted to have a rapidly progressive erythema of bilateral groins and scrotum, with purple discoloration of the scrotum, increasing vasopressor requirement, and continuous febrility, all of which were concerning for a necrotizing soft tissue infection.He was taken to the operating room for exploration of the right and left groins and scrotum to rule out a necrotizing infection.At the request of the cardiac surgery service, who requested we retrieve the guidewire retained in the right groin and visible on ct scan, we explored the groin wound and found and removed the guidewire, which was a green 0.035 inch guidewire with the j tip intact, removed as a single piece and sent to pathology.

• Brand Name: RAP FEMORAL VENOUS CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): ESTECH; 6217 centre park dr.; west chester, OH 45069
• MDR Report Key: 5507338
• MDR Text Key: 40586905
• Report Number: 5507338
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/17/2015,12/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 200-150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/17/2015
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 12/17/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: 2 LARGE BORE CANNULAS WERE REQUIRED IN OPEN HEART
• Patient Age: 75 YR
• Patient Weight: 107