MAUDE Adverse Event Report: ANGIOSCORE, INC. ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX); CATHETER, ANGIOPLASTY, CORONARY

Model Number 2200-2006

Device Problems Detachment of Device or Device Component (2907); Difficult to Advance (2920)

Patient Problems Atherosclerosis (1728); Peripheral Vascular Disease (2002)

Event Date 01/24/2014

Event Type  malfunction  

Event Description

Physician used a coronary balloon in distal, tortuous, and calcified peroneal vessel.Upon using force to deliver the angiosculpt across the difficult and resistant lesion, the hub reportedly broke away from the shaft.

Manufacturer Narrative

The pt info is unknown.Attempts to obtain the info have not been successful.The angiosculpt device was returned in two pieces.Visual examination confirmed the shaft broke approximately 1.5 mm from the distal end of the strain relief.The rx port is lacerated and a kink on the hypotube was observed.According to the instructions for use (ifu) for angiosculpt catheter, retained device components is listed as a possible adverse effect of the procedure.

• Brand Name: ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX)
• Type of Device: CATHETER, ANGIOPLASTY, CORONARY
• Manufacturer (Section D): ANGIOSCORE, INC.; fremont CA
• Manufacturer Contact: kent jones ; 5055 brandin court; fremont, CA 94538 ; 5109337904
• MDR Report Key: 3826241
• MDR Text Key: 4500688
• Report Number: 3005462046-2014-00005
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/03/2016
• Device Model Number: 2200-2006
• Device Catalogue Number: 2200-2006
• Device Lot Number: F13100001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/05/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2014
• Initial Date FDA Received: 02/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1