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

Model Number 2155-3040

Device Problem Failure to Advance (2524)

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

Event Date 09/03/2014

Event Type  Injury  

Event Description

The angiosculpt device was loaded on the guide wire without difficulty prior to entering pt.The physician was unable to cross the lesion with the angiosculpt device.The angiosculpt device was removed from pt where a damaged tip was noted.Add'l info received on (b)(6)2014: the angiosculpt device and guide wire were not removed as one unit.However after removal of the angiosculpt device, the guide wire was also removed and a new guide wire was inserted to successfully treat the lesion with add'l angiosculpt catheter.

Manufacturer Narrative

The angiosculpt device was unable to cross the lesion.The physician removed the device followed by the guide wire.The physician rewired the lesion to complete the procedure, thus resulting in prolongation of the case.The angiosculpt device was returned for eval.Visual examination found that the scoring element was lifted from the distal bond.It is possible that the angiosculpt device was damaged due to the attempt to cross the lesion.

• Brand Name: ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)
• Type of Device: CATHETER, ANGIOPLASTY, PERIOHERAL
• Manufacturer (Section D): ANGIOSCORE, INC.; fremont CA
• Manufacturer Contact: kent jones ; 5055 brandin court; fremont, CA 94538 ; 5109337904
• MDR Report Key: 4143972
• MDR Text Key: 4913354
• Report Number: 3005462046-2014-00031
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101735
• 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: 09/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2017
• Device Model Number: 2155-3040
• Device Catalogue Number: 2155-3040
• Device Lot Number: F14040043
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/25/2011
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2014
• 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: 6F GUIDE CATHETER; 6F INTRODUCER SHEATH,; MFR'S UNK - 0.014" GUIDE WIRE,
• Patient Outcome(s): Hospitalization
• Patient Age: 66 YR
• Patient Weight: 117