MAUDE Adverse Event Report: STRAUB MEDICAL AG ROTAREX ROTATIONAL EXCISIONAL ATHERECTOMY SYSTEM; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number 80237

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

A helical screw on the rotarex devices fractured during procedure.No patient injury.Device was removed in one piece.Another rotarex device was opened and it fractured as well.There are 2 separate devices.Fda safety report id # (b)(4).

• Brand Name: ROTAREX ROTATIONAL EXCISIONAL ATHERECTOMY SYSTEM
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): STRAUB MEDICAL AG; wangs ; SZ
• MDR Report Key: 12032372
• MDR Text Key: 257482575
• Report Number: MW5101983
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 07640142810582
• UDI-Public: 07640142810582
• 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: 06/16/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/05/2023
• Device Model Number: 80237
• Device Catalogue Number: 80237
• Device Lot Number: 201284
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1