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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 Use of Device Problem (1670); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/16/2020
Event Type  malfunction  
Manufacturer Narrative
Translation of evaluation summary report to english.
 
Event Description
Femoral access with cross-over approach. Start of the procedure and installation and of the rotarex catheter following the ifus. Start of use of the rotarex catheter though the cross over introducer sheath with no problem. While using the catheter, it seemed to the physician that the screw was elongated. Retraction of the catheter through the introducer sheath together with the guide wire. It seemed impossible to the physician to finish the thrombectomy with the rotarex catheter, this is why he decided to take a angiojet catheter. Procedure done with no harm to the patient nor loss of time.
 
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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 Key10755393
MDR Text Key213701551
Report Number3008439199-2020-00050
Device Sequence Number1
Product Code MCW
UDI-Device Identifier07640142810285
UDI-Public7640142810285
Combination Product (y/n)N
Reporter Country CodeSZ
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
Report Date 10/01/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/29/2020
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 Number80219
Device Lot Number200547
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/07/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/01/2020
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

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