FDA Adverse Event Malfunction Summary report: N

MYNXGRIP VASCULAR CLOSURE DEVICE 5F

MDR report key: 2810248 · Received October 31, 2012

Report

Report Number: 3004939290-2012-00389
Event Type: Malfunction
Date Received: October 31, 2012
Date of Event: October 3, 2012
Report Date: October 3, 2012
Manufacturer: ACCESSCLOSURE, INC.
Product Code: MGB
PMA / PMN Number: P040044
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, 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 AND NO RETURNED DEVICE FOR PHYSICAL INVESTIGATION, THE REPORTED EVENT COULD NOT BE CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. THE REVIEW OF THE LHR (LOT F1222601) 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 SALE PROFESSIONAL THAT (B)(6) FEMALE PATIENT UNDERWENT AN INTERVENTIONAL PERIPHERAL PROCEDURE ON (B)(6) 2012. ACCESS WAS OBTAINED VIA A 5F SHEATH (MODEL UNKNOWN). A PRE-PROCEDURE FEMORAL ANGIOGRAM SHOWED PRESENCE OF PVD/CALCIUM IN THE VICINITY OF THE ACCESS SITE AND THE VESSEL SIZE APPROXIMATELY 7MM. FOLLOWING THE PROCEDURE, THE PHYSICIAN WHO IS IN TRAINING, SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 5F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT THE BALLOON RUPTURED AT THE SECOND STOP. THE DEVICE WAS REMOVED AND THE PATIENT WAS CONVERTED TO APPROXIMATELY 12 MINUTES OF MANUAL COMPRESSION IN WHICH TIME HEMOSTASIS WAS ACHIEVED. THE PATIENT WAS AMBULATED AND DISCHARGED ON (B)(6) 2012 WITH NO REPORTED CLINICAL SEQUELA.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MYNXGRIP VASCULAR CLOSURE DEVICE 5F	MGB	MGB	ACCESSCLOSURE, INC.	MX5021	F1222601

Patients

Seq	Age	Sex	Outcome	Treatment
1	78 YR