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

Model Number 2200-3510

Device Problem Burst Container or Vessel (1074)

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

Event Date 09/04/2014

Event Type  malfunction  

Event Description

The catheter was inflated to 22 atm (above rated burst pressure of 16 atm) at a highly calcified lesion and balloon ruptured.Other company's deb catheter was used and the procedure was completed.

Manufacturer Narrative

The patient information is unknown.The hospital declined to provide the information.The angiosculpt device was returned for evaluation.Visual examination confirmed that the rx port was slightly lacerated.During functional testing, the balloon was inflated to 2 atm with a longitudinal tear observed in the distal section of the balloon.It is possible that the severly calcified lesion caused or contributed to the balloon burst.The physician inflated the balloon to 22 atm which is above the rbp of 16 atm.

• 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: 4137589
• MDR Text Key: 4946344
• Report Number: 3005462046-2014-00028
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2017
• Device Model Number: 2200-3510
• Device Catalogue Number: 2200-3510
• Device Lot Number: F14010053
• Other Device ID Number: M3702200351011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2014
• 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
• Treatment: AND GUIDE CATHETER.; MANUFACTURERS AND SIZES UNKNOWN: GUIDE WIRE