MAUDE Adverse Event Report: ANGIOSCORE, INC. ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW); CATHETER, ANGIOPLASTY, PERIPHERAL

Model Number 2092-6040

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Occlusion (1984)

Event Date 02/16/2015

Event Type  malfunction  

Event Description

The catheter was used for shunt pta.The anastomotic part for shunt was highly tortuous and the lesion was antithrombotic and occluded.The balloon was inflated more than 40 times at a maximum inflation pressure of 16 atm and a maximum inflation period of 5 minutes.When the physician removed the catheter outside the body, she found a protruding object at the tip.It was a little hard for the physician to make the catheter pass the anastomotic part, but no resistance occurred when the catheter was removed.The procedure was completed with the relevant catheter.

Manufacturer Narrative

The patient's age or dob, gender, and weight are unknown.This information was not available from the facility.Based on the photo provided by the facility, a distal bond peel was observed.(b)(4).The angiosculpt device was not returned, thus no evaluation performed.The user inflated the device over the rbp of 14 atm.Per the ifu, retained device component is listed as a possible adverse effect of the procedure.Placeholder.

• Brand Name: ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL
• Manufacturer (Section D): ANGIOSCORE, INC.; fremont CA
• Manufacturer (Section G): ANGIOSCORE, INC.
• Manufacturer Contact: florie cazem ; 5055 brandin court; fremont, CA 94538 ; 510933-792
• MDR Report Key: 4552379
• MDR Text Key: 5525312
• Report Number: 3005462046-2015-00006
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K100303
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/10/2017
• Device Model Number: 2092-6040
• Device Catalogue Number: 2092-6040
• Device Lot Number: F14070007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2014
• 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: MFG UNK: 0.018" GUIDE WIRE, 6F INTRODUCER SHEATH