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

Model Number 2200-2510

Device Problems Detachment Of Device Component (1104); Material Deformation (2976)

Patient Problems Atherosclerosis (1728); Ischemic Heart Disease (2493)

Event Date 12/20/2013

Event Type  malfunction  

Manufacturer Narrative

The pt's weight is unk.The hospital was not able to provide the information.As a conservative measure, an mdr is being submitted because the transition tubing separated from the proximal bond but remained intact to the device.The angiosculpt device was received for evaluation.Visual examination confirmed a bent and damaged scoring element.The distal bond is damaged and the intermediate bond is over the proximal marker band.The rx port is lacerated and the shaft is damaged and twisted.The transition tubing is twisted and separated at the proximal bond but remained intact to the intermediate bond.Based on the lab analysis, it leads to suggest that the device experienced excessive exertion of force applied by the user.According to the instructions for use (ifu) for the angiosculpt catheter, retained device components is listed as a possible adverse effect of the procedure.

Event Description

The scoring element was disfigured.No other information from the hospital could be obtained.

• 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: 3815835
• MDR Text Key: 15881832
• Report Number: 3005462046-2014-00007
• 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: 01/28/2014

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: 04/08/2016
• Device Model Number: 2200-2510
• Device Catalogue Number: 2200-2510
• Device Lot Number: F13040005
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/05/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2014
• Initial Date FDA Received: 03/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2013
• 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
• Treatment: MANUFACTURER UNK - 0.014" GUIDE WIRE
• Patient Age: 71 YR