FDA Adverse Event Other Summary report: N

ICAST COVERED STENT

MDR report key: 1242519 · Received November 21, 2008

Report

Report Number: 1219977-2008-00007
Event Type: Other
Date Received: November 21, 2008
Date of Event: September 18, 2008
Report Date: September 24, 2008
Manufacturer: ATRIUM MEDICAL CORP.
Product Code: NIO
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NC, US
Reporter Occupation: RISK MANAGER

Narratives

Additional Manufacturer Narrative · 1

ANALYSIS OF THE CATHETER YIELDED THAT THE SHAFT HAD BEEN SNAPPED AT THE PROXIMAL WELD OF THE BALLOON. THE PROXIMAL WELD WAS STILL INTACT AND THE BALLOON STILL FIRMLY ATTACHED. THERE WAS EVIDENCE OF THE SHAFT NECKING DOWN JUST PROXIMAL TO THE LOCATION THAT YIELDED. UPON REVIEWING THE BALLOON, IT WAS NOTED THAT THERE WAS STILL FLUID INSIDE THE BALLOON, MAINLY AT THE DISTAL END. BASED ON THIS INFO, IT CAN BE SURMISED THAT ADEQUATE TIME FOR DEFLATION WAS NOT PROVIDED. IF ADEQUATE TIME FOR DEFLATION IS NOT PROVIDED, FLUID IS FORCED INTO THE DISTAL END OF THE BALLOON AS THE BALLOON IS PULLED BACK INTO THE INTRODUCER SHEATH. THIS CAUSES THE DISTAL END OF THE BALLOON TO INFLATE. CONTINUING TO PULL ON THE PROXIMAL END OF THE CATHETER WILL CAUSE THE SHAFT TO NECK DOWN AND EVENTUALLY SNAP AT THE PROXIMAL END OF THE BALLOON.

Description of Event or Problem · 1

THE PT WAS IN THE CATH LAB UNDERGOING A PTA AND STENT OF THE LEFT COMMON ILIAC ARTERY. THE STENT HAD BEEN DELIVERED AND ON RETRIEVAL OF THE ATRIUM STENT DELIVERED BALLOON, IT WAS NOTED THAT THE BALLOON WAS DISPLACED OFF THE DELIVERY SHAFT. IT WAS RETRIEVED USING A #7 GOOSENECK SNARE. THE PT WAS DISCHARGED HOME THE FOLLOWING DAY IN STABLE CONDITION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ICAST COVERED STENT	NONE	NIO	ATRIUM MEDICAL CORP.	85415	1013079216

Patients

Seq	Age	Sex	Outcome	Treatment
1	40 YR		Required Intervention