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

Model Number 2200-2015

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/29/2014

Event Type  malfunction  

Event Description

During preparation for use, when removed from the hoop, the scoring element wires were displaced.

Manufacturer Narrative

The patient information is none.The device was not used in the patient.An overflow lifting of material (peel) at the distal bond was observed during lab analysis.The angiosculpt device was returned for evaluation.Visual examination found an overflow lifting of material at the distal bond but remained intact to the device.The scoring element was lifted at the distal end.Per the ifu, retained device component is listed as a possible adverse effect of the procedure.Placeholder.

• Brand Name: ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX)
• Type of Device: CATHETER, ANGIOPLASTY, CORONARY
• 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: 4587751
• MDR Text Key: 19497808
• Report Number: 3005462046-2015-00007
• 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: 02/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/25/2017
• Device Model Number: 2200-2015
• Device Catalogue Number: 2200-2015
• Device Lot Number: F14070038
• Other Device ID Number: M3702200201510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2015
• Initial Date FDA Received: 03/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2014
• 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