FDA Adverse Event Malfunction Summary report: N

ANGIOSCULPT PTA SCORING BALLOON CATHETER

MDR report key: 1972506 · Received December 30, 2010

Report

Report Number: 3005462046-2010-00034
Event Type: Malfunction
Date Received: December 30, 2010
Date of Event: March 8, 2010
Report Date: March 8, 2010
Manufacturer: ANGIOSCORE, INC.
Product Code: LIT
PMA / PMN Number: K080151
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GA, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THE DISTAL TIP DETACHMENT OCCURRED AND WAS DETECTED PRIOR TO USE IN PT AND THE CATHETER WAS NOT USED IN A PT. THUS, THERE WAS NO PT INVOLVEMENT. ADDITIONALLY, THE CUSTOMER HAD DECLINED TO PROVIDE THE REQUESTED PT INFO. EVAL SUMMARY: VISUAL EXAMINATION OF THE RETURNED CATHETER FOUND THAT THE DISTAL TIP OF THE CATHETER WAS DETACHED. THERE WAS NO PRESENCE OF BLOOD ON THE DEVICE. UPON FOLLOW-UP, THE CUSTOMER REPORTED THAT THE DETACHED DISTAL TIP WAS RETURNED ALONG WITH THE CATHETER. HOWEVER, THE DETACHED DISTAL TIP COULD NOT BE LOCATED DURING INSPECTION OF THE RETURNED PACKAGE. CONCLUSIONS: THE DISTAL TIP WAS REPORTED TO HAVE DETACHED WHILE LOADING THE CATHETER ONTO THE GUIDE WIRE (PRIOR TO INSERTION IN PT).

Description of Event or Problem · 1

INITIAL INFO REC'D: BLUE TIP CAME OFF OF THE DEVICE DURING PREP AND PRIOR TO IT BEING INSERTED INTO THE PT. FOLLOW-UP INFO REC'D: ANGIOSCULPT GOT STUCK ON THE WIRE WHILE ADVANCING IT, AT THAT POINT, PART OF THE BLUE TIP CAME OFF. IT NEVER WENT INTO THE PT'S BODY AND THEY USED ANOTHER ANGIOSCULPT SUCCESSFULLY IN ITS PLACE. THE GUIDE CATHETER WAS A 6F PINNACLE 45CM WITH A SPARTACORE 0.014 WIRE AND THE ANGIOSCULPT WAS A 2.5X20 OTW.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ANGIOSCULPT PTA SCORING BALLOON CATHETER		LIT	ANGIOSCORE, INC.	2039-2520	F09080029

Patients

Seq	Age	Sex	Outcome	Treatment
1