MAUDE Adverse Event Report: STRAUB MEDICAL AG ROTAREXS 6F 110CM (STRAUB MEDICAL); ATHERECTOMY CATHETER

Model Number SET ROTAREX®S 6F X 110CM

Device Problems Defective Device (2588); Mechanical Jam (2983)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/29/2020

Event Type  malfunction  

Manufacturer Narrative

Suspect device not returned yet.Company representative and user will be contacted again if this sample can be returned for investigation.

Event Description

Initially the rotarex catheter was working well when inserted into the patient for atherectomy of the sfa.After a minute or two of use the rotarex catheter would not activate properly and create helical vortex.Flow was not being carried through the archimedes screw throughout the rotarex to the collection bag.An audible change in pitch was recognized and trying to use the "return" and flush procedures detailed in the ifu did not seem to work and the catheter was not used to complete the procedure.No harm to the patient.Intervention was completed with balloons and guiding catheters.

• Brand Name: ROTAREXS 6F 110CM (STRAUB MEDICAL)
• Type of Device: ATHERECTOMY CATHETER
• Manufacturer (Section D): STRAUB MEDICAL AG; straubstrasse 12; wangs, sankt gallen 7323 ; SZ 7323
• MDR Report Key: 10230885
• MDR Text Key: 199710163
• Report Number: 3008439199-2020-00010
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 07640142810575
• UDI-Public: 7640142810575
• Combination Product (y/n): N
• PMA/PMN Number: K172315
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/13/2023
• Device Model Number: SET ROTAREX®S 6F X 110CM
• Device Catalogue Number: 80236
• Device Lot Number: 200135
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention