MYNX VASCULAR CLOSURE DEVICE 6F/7F

Report

Report Number: 3004939290-2012-00193
Event Type: Injury
Date Received: July 10, 2012
Date of Event: January 6, 2012
Report Date: June 11, 2012
Manufacturer: ACCESSCLOSURE, INC.
Product Code: MGB
PMA / PMN Number: P040044
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE WAS NOT RETURNED; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE INFO PROVIDED, THE MOST LIKELY CAUSE OF THE REPORTED TRANSFUSION WAS HEMATOMA. A REVIEW OF THE LHR WAS NOT POSSIBLE AS THE LOT NUMBER WAS NOT PROVIDED.

Description of Event or Problem · 1

IT WAS REPORTED BY THE ACI VASCULAR CLOSURE SPECIALIST THAT A PT UNDERWENT A LEFT CARDIAC CATHETERIZATION PROCEDURE ON (B)(6) 2012. ACCESS WAS OBTAINED AT THE RIGHT FEMORAL ARTERY. THE PT WAS ANTICOAGULATED WITH EFFIENT, ANGIOMAX, INTEGRILIN, ASA, AND HEPARIN. FOLLOWING THE PROCEDURE, THE PHYSICIAN, SELECTED THE MYNX VASCULAR CLOSURE DEVICE TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT THE SHEATH WAS PULLED AND THE MYNX DEVICE WAS DEPLOYED. PRESSURE WAS APPLIED FOR 5 MINS AND HEMOSTASIS WAS ACHIEVED. THE PT'S RIGHT GROIN WAS DOCUMENTED AS UNREMARKABLE AND NO BLEEDING WAS NOTED IN ALL OF THE NEUROVASCULAR CHECKS. THE PT'S HGB WAS 9.5 PRE-CATHETERIZATION AND WENT DOWN TO 8.4 WITHIN A 72 HOUR PERIOD FOLLOWING THE CATHETERIZATION PROCEDURE. THE PHYSICIAN DOCUMENTED A "MILD" HEMATOMA ON THE PT'S RIGHT GROIN ON (B)(6) 2012. THE PT RECEIVED 2 UNITS OF PRBCS ON (B)(6) 2012. THERE WAS NO DOCUMENTED ACTIVE GI BLEEDING, DURING THE HOSPITALIZATION PRIOR TO THE CATHETERIZATION/PCI PROCEDURES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MYNX VASCULAR CLOSURE DEVICE 6F/7F		MGB	ACCESSCLOSURE, INC.	MX6700	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention	EFFIENT\| ANGIOMAX\| HEPARIN\| INTEGRILLIN\| ASA