MYNX VASCULAR CLOSURE DEVICE

Report

Report Number: 3004939290-2008-00024
Event Type: Injury
Date Received: April 25, 2008
Date of Event: March 27, 2008
Report Date: April 23, 2008
Manufacturer: ACCESSCLOSURE, INC.
Product Code: MGB
PMA / PMN Number: P040044
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE WAS NOT RETURNED TO ACI FOR EVALUATION AND THE DEVICE'S LOT NUMBER WAS NOT PROVIDED FOR LOT HISTORY REVIEW. BASED ON THE INFORMATION PROVIDED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE EMBOLISM COULD NOT BE DETERMINED. THE EXCISED MATERIAL WAS NOT SENT TO PATHOLOGY, THEREFORE THE CONTENTS OF THE MATERIAL REMAIN UNKNOWN. THERE IS NO EVIDENCE TO SUGGEST THAT THE MYNX DEVICE DID NOT MEET SPECIFICATIONS OR PERFORM AS INTENDED PER IFU. PER THE MYNX IFU, THE SAFETY AND EFFECTIVENESS OF THE MYNX HAS NOT BEEN ESTABLISHED IN PATIENTS WITH CLINICALLY SIGNIFICANT PVD IN THE VICINITY OF THE PUNCTURE.

Description of Event or Problem · 1

A MALE WITH HISTORY OF PVD AND HYPERTENSION UNDERWENT AN UNCOMPLICATED ILIAC INTERVENTION IN 2008. PERI-PROCEDURAL HEPARIN WAS ADMINISTERED. A 6F SHEATH WAS INSERTED INTO THE CFA, WITH VISIBLE PAD AND/OR CALCIUM ON THE PUNCTURE SITE ARTERIOGRAM. THE PHYSICIAN PROCEEDED TO USE THE MYNX DEVICE IN WHICH HEMOSTASIS WAS ACHIEVED. LATER THAT DAY, THE PATIENT EXPERIENCED COMPLAINTS OF ISCHEMIC PAIN, AND WAS SENT TO VASCULAR SURGERY FOR EMBOLECTOMY. THE PATIENT REPORTEDLY TOLERATED THE PROCEDURE WELL AND WITHOUT COMPLICATION, AND WAS DISCHARGED THE NEXT DAY, WITHOUT FURTHER INCIDENT.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1	70 YR		Required Intervention	PERI-PROCEDURAL MEDS INCLUDED HEPARIN\| PRE-PROCEDURAL MEDS INCLUDED ASA