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

Model Number 2076-5040

Device Problem Material Frayed (1262)

Patient Problems Atherosclerosis (1728); Peripheral Vascular Disease (2002)

Event Date 11/26/2014

Event Type  Malfunction  

Event Description

After balloon inflation, the angiosculpt device was removed from the pt. Upon removal, the user found a problem with the distal bond. No pt injury occurred but the user requested an investigation of the distal bond region.

Manufacturer Narrative

The pt info is unknown. The hospital declined to provide the info. The angiosculpt device was returned for eval. Visual examination found a distal bond peel but remained intact to the device. The balloon is inverted at the distal end and the transition tubing is twisted. Per the ifu, retained device component is listed as a possible adverse effect of the procedure.

• Brand Name: ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL
• Manufacturer (Section D): ANGIOSCORE, INC.; fremont CA
• Manufacturer Contact: robert greenleaf ; 5055 brandin court; fremont, CA 94538 ; 7194472398
• MDR Report Key: 4437694
• MDR Text Key: 5317612
• Report Number: 3005462046-2015-00001
• 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

• Type of Report: Initial
• Report Date: 11/27/2014

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 01/15/2015
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 03/03/2017
• Device MODEL Number: 2076-5040
• Device Catalogue Number: 2076-5040
• Device LOT Number: F14020039
• Was Device Available For Evaluation?: Yes
• Date Returned to Manufacturer: 12/26/2014
• Is The Reporter A Health Professional?: Yes
• Date Manufacturer Received: 12/26/2014
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 03/18/2014
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient TREATMENT DATA

Date Received: 01/15/2015 Patient Sequence Number: 1

Treatment

GUIDE CATHETER; INTRODUCER SHEATH; MFR AND SIZES ARE UNK: GUIDE WIRE