FDA Adverse Event Injury Summary report: N

MYNX GRIP 6F/7F

MDR report key: 5771571 · Received July 6, 2016

Report

Report Number
5771571
Event Type
Injury
Date Received
July 6, 2016
Date of Event
June 16, 2016
Report Date
June 30, 2016
Manufacturer
ACCESSCLOSURE, INC., A CARDINAL HEALTH COMPANY
Product Code
MGB
Adverse Event
Yes
Report Source
User Facility report
Reporter Location
MN, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

A PATIENT WAS BROUGHT TO THE CARDIAC CATHETERIZATION LABORATORY FOR AN EMERGENT LEFT HEART CATH AND PERCUTANEOUS CORONARY INTERVENTION. DURING THE PROCEDURE, THE PERCUTANEOUS ACCESS WAS PERFORMED THROUGH THE RIGHT FEMORAL ARTERY. A 6 FRENCH SHEATH WAS INSERTED. THE PUNCTURE POINT WAS SUCCESSFULLY CLOSED WITH A MYNX VASCULAR CLOSURE DEVICE APPROXIMATELY 1.5 MONTHS LATER, THE PATIENT PRESENTED BACK TO THE HOSPITAL WITH A LARGE PUS DRAINING ABSCESS IN THE RIGHT GROIN, LOW GRADE FEVERS, PAIN, CHILLS AND TACHYCARDIA. A SURGEON CONSULTED AND THE PATIENT WAS BROUGHT TO THE OPERATING ROOM FOR IRRIGATION AND DEBRIDEMENT OF THE RIGHT GROIN. SURGICAL FINDINGS WERE THAT THERE WAS A RETAINED MYNX CLOSURE DEVICE IN A SUBCUTANEOUS ABSCESS. IT DID NOT APPEAR TO TRACK TO THE ARTERY ITSELF. THE MYNX CLOSURE DEVICE WAS REMOVED. (THE MYNX CLOSURE DEVICE IS GENERALLY RESORBED BY THE BODY WITHIN 30 DAYS.) FINAL GROIN CULTURE RESULT SHOWED MODERATE GROWN OF STREPTOCOCCUS GROUP F; MODERATE GRAM POSITIVE COCCI, MODERATE GRAM NEGATIVE COCCOBACILLI. PATHOLOGY REPORT FINDINGS:GROSS - INFECTION CLOSURE DEVICE MYNX PLUG: TWO TAN/PINK SOFT TISSUES WITH BLOOD, 0.5 AND 1.2 CM IN GREATEST DIMENSION PATIENT WAS DISCHARGED AFTER SIX DAYS OF HOSPITALIZATION TO A TRANSITIONAL CARE FACILITY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
426558 MYNX GRIP 6F/7F DEVICE VASCULAR HEMOSTASIS MGB ACCESSCLOSURE, INC., A CARDINAL HEALTH COMPANY

Patients

Seq Age Sex Outcome Treatment
1 56 YR Hospitalization| O| R