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U.S. Department of Health and Human Services

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

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STRAUB MEDICAL AG ROTAREXS 6F 110CM (STRAUB MEDICAL) ATHERECTOMY CATHETER Back to Search Results
Model Number ROTAREX®S 6F X 110CM
Device Problems Break (1069); Mechanical Jam (2983)
Patient Problems Thrombosis (2100); Device Embedded In Tissue or Plaque (3165)
Event Date 03/25/2020
Event Type  Injury  
Manufacturer Narrative
Suspect device not returned yet. Return of suspect device is expected.
 
Event Description
Thrombosis was found in sfa. Anterograde puncture was performed. Straub guidewire was used. Syringe was used to flush the catheter before inserting into the body. Guidewire reached 15cm beyond the thrombosis. Catheter reached 2cm before the thrombosis and started the motor. At the beginning, blood was found flowing out. After around one minute, no blood flow was found. Big resistance was found when taking it out. About 10cm of the catheter head was left in the vessel. Knife and scissors were used to take the broken head out. Another new catheter was used to complete the operation.
 
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Brand NameROTAREXS 6F 110CM (STRAUB MEDICAL)
Type of DeviceATHERECTOMY 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 Key10013263
MDR Text Key189985357
Report Number3008439199-2020-00004
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K172315
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup,Followup,Followup
Report Date 04/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/13/2022
Device Model NumberROTAREX®S 6F X 110CM
Device Catalogue Number80208
Device Lot Number190253
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/22/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/01/2020
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 Treatment Data
Date Received: 04/30/2020 Patient Sequence Number: 1
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