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

Model Number SET ROTAREX®S 6F X 135CM

Device Problems Fracture (1260); Detachment of Device or Device Component (2907); Noise, Audible (3273)

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

Event Date 01/31/2021

Event Type  malfunction  

Manufacturer Narrative

Evaluation protocol not completed yet.

Event Description

Thrombosis was found in sma.Puncture was performed on left brachial artery.Straub guildwire was used.Syringe was used to flush the catheter before inserting into the body.Guildwire reached 15cm beyond the thrombosis.Catheter reached 2cm before the thrombosis and started the motor.Strange sound was heard and stop immediately and withdraw the catheter.The head of the catheter was found detached with the helix.Another new catheter was used to finish the operation.

• Brand Name: ROTAREX®S 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: 11423501
• MDR Text Key: 253576026
• Report Number: 3008439199-2021-00017
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 07640142810315
• UDI-Public: 7640142810315
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K172315
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/19/2023
• Device Model Number: SET ROTAREX®S 6F X 135CM
• Device Catalogue Number: 80202
• Device Lot Number: 200981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Date Manufacturer Received: 02/05/2021
• 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
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 62 KG