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

Model Number 2200-3015

Device Problems Disconnection (1171); Physical Resistance (2578)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/30/2015

Event Type  malfunction  

Manufacturer Narrative

Upon removal of the angiosculpt device, one side of the scoring element appeared disconnected from the balloon but remained intact to the device.(b)(6).The angiosculpt device was not returned, thus no evaluation performed.

Event Description

The angiosculpt device was inserted into the guide catheter but resistance was noted, thus the physician removed the device from the guide catheter.Upon removal, one side of the scoring element appeared disconnected from the balloon but remained intact to the device.A new angiosculpt device was used to complete the procedure.

• Brand Name: ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX)
• Type of Device: CATHETER, ANGIOPLASTY, CORONARY
• Manufacturer (Section D): ANGIOSCORE, INC; 5055 brandin court; fremont CA
• Manufacturer (Section G): ANGIOSCORE, INC
• Manufacturer Contact: florie cazem ; 5055 brandin court; fremont, CA 94538 ; 510933-792
• MDR Report Key: 5068080
• MDR Text Key: 26010887
• Report Number: 3005462046-2015-00023
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P050018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 09/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/02/2017
• Device Model Number: 2200-3015
• Device Catalogue Number: 2200-3015
• Device Lot Number: F14040001
• Other Device ID Number: M3702200301511
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2014
• 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