MAUDE Adverse Event Report: STRAUB MEDICAL AG ROTAREXS 6F 135CM (STRAUB MEDICAL); ATHERECTOMY CATHETER

Model Number ROTAREX®S 6F X 135CM

Device Problems Use of Device Problem (1670); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/09/2020

Event Type  malfunction  

Manufacturer Narrative

Summary evaluation was translated from (b)(6) to english language.

Event Description

According to the user's statement, "1x thrombectomy afs closure" was performed.After das control, a further pass should be performed."rotarex seems to work (and does not report an error); however, thrombectomy/aspiration no longer occurs.Extracorporeal test confirms no aspiration performance despite activated drive.

• Brand Name: ROTAREXS 6F 135CM (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: 10704777
• MDR Text Key: 212089478
• Report Number: 3008439199-2020-00049
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 07640142810315
• UDI-Public: 7640142810315
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K172315
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2022
• Device Model Number: ROTAREX®S 6F X 135CM
• Device Catalogue Number: 80202
• Device Lot Number: 191357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Date Manufacturer Received: 09/21/2020
• 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