MAUDE Adverse Event Report: STRAUB MEDICAL AG ROTAREXS 8F 110CM (STRAUB MEDICAL); ATHERECTOMY CATHETER

Model Number SET ROTAREX®S 8F X 110CM

Device Problems Break (1069); Fracture (1260)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/22/2021

Event Type  malfunction  

Manufacturer Narrative

Evaluation protocol not completed yet.This mdr (for complaint (b)(4)) was late due to wrong calculation of reporting deadline.Based on this fact a non-conformance (no.(b)(4)) was opened.Preliminary investigation of nc (b)(4): wrong calculation of report deadline.Isolated incident, never happened before.Immediate action of nc (b)(4): immediately report (b)(4)as initial 30 days report.Action of nc (b)(4): because the whole mdr process from straub medical (b)(4) was moved in the middle of april to affiliate organization at becton dickinson peripheral intervention, (b)(4) and there are only 5 remaining initial reports to be reported from straub medical (b)(4), the following verification action is proposed: on 05/03/2021, verify that the remaining five mdrs are reported according to the following correctly calculated deadlines.(b)(4).If all reports are up to date, nc (b)(4) can be closed.

Event Description

Broken helix of a 8f rotarex.Helix was broken during retraction of the catheter.They used a new device.

• Brand Name: ROTAREXS 8F 110CM (STRAUB MEDICAL)
• Type of Device: ATHERECTOMY CATHETER
• Manufacturer (Section D): STRAUB MEDICAL AG; straubstrasse 12; wangs, sankt gallen 7323 ; SZ 7323
• Manufacturer (Section G): STRAUB MEDICAL AG; straubstrasse 12; wangs, sankt gallen 7323 ; SZ 7323
• Manufacturer Contact: martin kvokacka ; straubstrasse 12; wangs, sankt gallen 7323 ; SZ 7323
• MDR Report Key: 11721574
• MDR Text Key: 261937351
• Report Number: 3008439199-2021-00033
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 07640142810391
• UDI-Public: 7640142810391
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K172315
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2023
• Device Model Number: SET ROTAREX®S 8F X 110CM
• Device Catalogue Number: 80224
• Device Lot Number: 210060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2021
• Date Manufacturer Received: 03/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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