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

Model Number 2249-60200

Device Problem Entrapment of Device (1212)

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

Event Date 01/14/2015

Event Type  Malfunction  

Event Description

When the physician removed the angiosculpt device, it was hung up on a very tight area of the sfa. Upon removal, it looked like the tip of the balloon malformed.

Manufacturer Narrative

The angiosculpt device was returned for eval. Visual examination found a section of the scoring element detached at the distal ring and damaged the distal bond. The transition tubing was stretched, necked, and damaged. The shaft was kinked in multiple areas. According to the info rec'd from the hosp, it is probably that the severely calcified lesion caused or contributed to the detachment of the scoring element ring. Per the ifu, a vessel dissection or a retained device component are possible adverse effects 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: 4491408
• MDR Text Key: 16851172
• Report Number: 3005462046-2015-00003
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: K133998
• 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: 01/14/2015

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 02/03/2015
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 06/24/2016
• Device MODEL Number: 2249-60200
• Device Catalogue Number: 2249-60200
• Device LOT Number: F14060037
• Was Device Available For Evaluation?: Yes
• Date Returned to Manufacturer: 01/21/2015
• Is The Reporter A Health Professional?: Yes
• Date Manufacturer Received: 01/21/2015
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 07/10/2014
• 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: 02/03/2015 Patient Sequence Number: 1

Treatment

0.014" GUIDE WIRE, MFR UNK; 6F INTRODUCER SHEATH, MFR UNK; 6F GUIDE CATHETER, MFR UNK