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

Model Number 2200-30158

Device Problems Detachment Of Device Component (1104); Use of Device Problem (1670)

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

Event Date 09/22/2014

Event Type  malfunction  

Event Description

The angiosculpt scoring element came off into the sheath.Additional info received on 10/09/2014: the nitinol cage pulled from the balloon o the way out of the tuohy-borst.The physician stated that they did not deflate the balloon all the way.

Manufacturer Narrative

The pt info is unk.The hospital was not able to provide the info.The angiosculpt device was returned for lab analysis.Visual examination confirmed the scoring element was stuck inside the 3-way tuohy-borst.The scoring element separated from the damaged distal bond and the damaged intermediate bond.Two scoring element strut rings broke at the distal section.The transition tubing was stretched and the rx port was lacerated.The user did not follow the ifu.Also, retained device component 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: 4177000
• MDR Text Key: 5155153
• Report Number: 3005462046-2014-00034
• 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: 09/23/2014

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: 06/16/2017
• Device Model Number: 2200-30158
• Device Catalogue Number: 2200-3015
• Device Lot Number: F14060025
• Other Device ID Number: M3702200301511
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/01/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/23/2014
• Initial Date FDA Received: 10/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2014
• 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: INTRODUCER SHEATH; GUIDE CATHETER; GUIDE WIRE; MFRS AND SIZES UNK: