MAUDE Adverse Event Report: STRAUB MEDICAL AG/BARD PERIPHERAL VASCULAR, INC. STRAUB MEDICAL SET ROTAREX S 6F 135 CM; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number REF 80237

Device Problems Difficult to Remove (1528); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 04/13/2021

Event Type  malfunction  

Event Description

Straub medical set rotarex 6f 135 cm device malfunctioned.Once deployed the surgeon had difficulty retrieving the device from the artery.Fda safety report id# (b)(4).

• Brand Name: STRAUB MEDICAL SET ROTAREX S 6F 135 CM
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): STRAUB MEDICAL AG/BARD PERIPHERAL VASCULAR, INC.
• MDR Report Key: 11692995
• MDR Text Key: 246476155
• Report Number: MW5100848
• Device Sequence Number: 1
• Product Code: MCW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/10/2023
• Device Model Number: REF 80237
• Device Lot Number: 210055
• 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