MAUDE Adverse Event Report: ANGIOSCORE ANGIOSCULPT; PTCA BALLOON

Model Number ANDIOSCULPT 2.5X10

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 01/15/2016

Event Type  malfunction  

Event Description

Tip broken off of 2.5 x 10 angioscore balloon while removing from wire.

• Brand Name: ANGIOSCULPT
• Type of Device: PTCA BALLOON
• Manufacturer (Section D): ANGIOSCORE; brandin court CA 94538
• MDR Report Key: 5394134
• MDR Text Key: 36970162
• Report Number: MW5059670
• Device Sequence Number: 1
• Product Code: LIT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/19/2016

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: 01/09/2018
• Device Model Number: ANDIOSCULPT 2.5X10
• Device Catalogue Number: 2200-2510
• Device Lot Number: F15010006
• Other Device ID Number: +M3702200251010
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/19/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 128