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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 SET ROTAREX®S 6F X 110CM
Device Problems Fracture (1260); Difficult to Insert (1316); Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/11/2020
Event Type  malfunction  
Manufacturer Narrative
Suspect device not returned yet. The return of suspect device is expected.
 
Event Description
Thrombosis was found in popliteal 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. At the beginning, blood was found flowing out. After around one minute, it is very difficult to advance the catheter. Withdraw the catheter, flush the catheter and found the tip of the catheter and the guildwire were broken and separated. Another 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 Key10668998
MDR Text Key212542187
Report Number3008439199-2020-00047
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,health profession
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 09/14/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSET ROTAREX®S 6F X 110CM
Device Catalogue Number80219
Device Lot Number191356
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/15/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/14/2020
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

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