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

Model Number 2200-3015

Device Problem Leak/Splash (1354)

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

Event Date 03/10/2014

Event Type  Injury  

Event Description

The pt had in-stent restenosis.The physician attempted to balloon the lesion with an angiosculpt balloon.The balloon was inflated twice to 8 atm for 30 seconds.The balloon was then removed out of the body and an angiogram was performed and showed the lesion was still present.The balloon was reintroduced to the rca and was inflated to 12 atm.The indeflator was unable to hold pressure so the device was deflated and removed from the pt.An angiogram without contrast injected after showed contrast in the vessel and an air embolism.The pt went bradycardic and her blood pressure dropped.The ekg showed st elevation.The pt was given medications form the nurse and was stabilized.

Manufacturer Narrative

An air embolism occurred during use of the angiosculpt device.The pt was given medication, thus resulting in additional intervention.The angiosculpt device was returned for evaluation.Visual examination confirmed the balloon had been inflated and the rx port is lacerated.During functional testing, the balloon was inflated to 2 atm and a pinhole leak was observed distal to the proximal marker band.Per the angiosculpt ifu, embolism 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: 3760862
• MDR Text Key: 4417966
• Report Number: 3005462046-2014-00010
• 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: 03/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/25/2016
• Device Model Number: 2200-3015
• Device Catalogue Number: 2200-3015
• Device Lot Number: F13090067
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/18/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2014
• Initial Date FDA Received: 04/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2013
• 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: 0.014" GUIDE WIRE/6F INTRODUCER SHEATH/6F GUIDE; CATHETER
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 57