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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 Complete Blockage (1094); Material Fragmentation (1261)
Patient Problems Embolism (1829); Foreign Body In Patient (2687)
Event Date 10/23/2020
Event Type  malfunction  
Manufacturer Narrative
Suspect device not investigated yet.
 
Event Description
Antergrade acces from cfa, occluded sfa after ring strip 13 months ago with distal sfa viabahn. Total occlusion length of 30cm. 6fr sheath with 5000 ie heparine at start of procedure. Easy proximal part with ff rotarex, in stent minimal flow. Pta performed at proximal edge of stent and continue with rotarex, good flow and perfect cleaning of stent. Proximal and distal native vessel treated with pta with very good result. Wire came out of patient with a brush of fabric around the tip.
 
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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 Key10886043
MDR Text Key218652171
Report Number3008439199-2020-00061
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeNL
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
Report Date 10/26/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberROTAREX®S 6F X 110CM
Device Catalogue Number80208
Device Lot Number200789
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/19/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/26/2020
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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