MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

Report

Report Number: 3004939290-2012-00208
Event Type: Injury
Date Received: July 2, 2012
Date of Event: June 15, 2012
Report Date: June 15, 2012
Manufacturer: ACCESSCLOSURE, INC.
Product Code: MGB
PMA / PMN Number: P040044
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: KY, 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 INFORMATION PROVIDED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THE REVIEW OF THE LHR (LOT F1214502) INDICATED THAT THE DEVICE LOT MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT.

Description of Event or Problem · 1

IT WAS REPORTED BY THE ACI SALES PROFESSIONAL THAT A MALE PATIENT UNDERWENT AN INTERVENTIONAL CORONARY CATHETERIZATION PROCEDURE ON (B)(6) 2012. ACCESS WAS OBTAINED AT THE COMMON FEMORAL ARTERY, VIA A 6F TERUMO SHEATH. A PRE-PROCEDURE FEMORAL ANGIOGRAM SHOWED THE VESSEL SIZE TO BE APPROXIMATELY 7 MM. FOLLOWING THE PROCEDURE, THE PHYSICIAN, WHO WAS IN TRAINING, SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT POST MYNX DEPLOYMENT, THERE WAS A CONSIDERABLE AMOUNT OF TRACT OOZE. "THE STAFF DOUBLE CHECKED THE INTEGRILIN DOSE, AND DISCOVERED THAT THE PATIENT WAS BEING OVERDOSED WHILE INFUSING. THE DOSE WAS EXACTLY DOUBLE THE CORRECT DOSING REGIMEN. GIVEN THESE CIRCUMSTANCES, THE PHYSICIAN OPTED FOR A FEMOSTOP TO DEAL WITH THE OOZING. THERE WAS NO HEMATOMA OR BLEEDING ISSUES; JUST OOZING." THE PATIENT WAS REPORTED AS HOSPITALIZED (NOT DUE TO MYNX DEVICE). NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F		MGB	ACCESSCLOSURE, INC.	MX6721	F1214502

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention	INTEGRILLIN