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

Model Number 2200-3006

Device Problems Detachment Of Device Component (1104); Failure to Advance (2524)

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

Event Date 10/15/2014

Event Type  malfunction  

Event Description

The physician used an angiosculpt device to treat the lad, but was unable to cross the lesion.During withdrawal, the balloon delivery shaft broke after removing from the guide wire.

Manufacturer Narrative

The pt's weight is unk.The hospital was unable to provide the info.The angiosculpt device was returned in two pieces.Visual examination found wrinkles on the intermediate shaft.The hypotube shaft separated approx 16.5 cm distal from the distal end of the strain relief.Per the ifu, retained device components is listed as 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: 4257833
• MDR Text Key: 5110260
• Report Number: 3005462046-2014-00036
• 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: Nurse
• Type of Report: Initial
• Report Date: 10/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2016
• Device Model Number: 2200-3006
• Device Catalogue Number: 2200-3006
• Device Lot Number: F13010046
• Other Device ID Number: M3702200300611
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/03/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2013
• 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: GUIDE WIRE (SIZE UNK); UNK MFR: 6F INTRODUCER SHEATH; 6F GUIDE CATHETER
• Patient Age: 80 YR