MYNXGRIP VASCULAR CLOSURE DEVICE 5F

Report

Report Number: 3004939290-2012-00244
Event Type: Injury
Date Received: August 2, 2012
Date of Event: July 5, 2012
Report Date: July 5, 2012
Manufacturer: ACCESS CLOSURE, INC.
Product Code: MGB
PMA / PMN Number: P040044
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY, 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 F1212803) 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 (B)(6) FEMALE PT UNDERWENT AN INTERVENTION AL PERIPHERAL PROCEDURE ON (B)(6) 2012. ACCESS WAS OBTAINED AT THE FEMORAL HEAD, VIA A 5F SHEATH (MODEL UNK). A PRE-PROCEDURE FEMORAL ANGIOGRAM SHOWED NO PCD/CALCIUM IN THE VICINITY OF THE ACCESS SITE, AND THE VESSEL APPROXIMATELY 6 MM IN SIZE. FOLLOWING THE PROCEDURE, THE PHYSICIAN, SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 5F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT THE BALLOON CAME OUT OF THE ARTERIOTOMY WHILE THE PHYSICIAN WAS PULLING BACK THE SHEATH. THE PHYSICIAN "DID NOT FEEL THERE WAS TOO MUCH TENSION". THE BALLOON WAS INFLATED WHEN THE BALLOON CAME OUT THROUGH THE ARTERIOTOMY. THE PHYSICIAN REMOVED THE DEVICE AND CONVERTED THE PT TO 40 MINUTES OF MANUAL COMPRESSION. THE PT WAS REPORTED AS FINE. IT WAS ALSO REPORTED THAT UPON INSPECTION OF THE DEVICE, THE BLACK SHUTTLE TUBE WAS CRACKED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MYNXGRIP VASCULAR CLOSURE DEVICE 5F		MGB	ACCESS CLOSURE, INC.	MX5021	F1212803

Patients

Seq	Age	Sex	Outcome	Treatment
1	74 YR		Required Intervention