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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRAUB MEDICAL AG ROTAREXS 6F 135CM (STRAUB MEDICAL) ATHERECTOMY CATHETER

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STRAUB MEDICAL AG ROTAREXS 6F 135CM (STRAUB MEDICAL) ATHERECTOMY CATHETER Back to Search Results
Model Number SET ROTAREX®S 6F X 135CM
Device Problems Fracture (1260); Failure to Advance (2524); Noise, Audible (3273)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/30/2020
Event Type  malfunction  
Manufacturer Narrative
Evaluation protocol not completed yet.
 
Event Description
Up and over approach. May be occluded stent which was treated earlier. Rep told doctor too tight bifurcation and shouldn't use rotarex. Doctor upsized sheath to 7f, rep advised not to use. Sheath: cook ansel (not hiflex). During removing rotarex and keeps device turned on. Heard change in pitch to whirling sound. Noticed helix wasn't moving. Grabbed the helix and pulled it out with the catheter. Doctor acknowledged this wasn't the right device for the case. Overall doctor very pleased with outcome and device.
 
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Brand NameROTAREXS 6F 135CM (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 Key10756085
MDR Text Key217959121
Report Number3008439199-2020-00051
Device Sequence Number1
Product Code MCW
UDI-Device Identifier07640142810582
UDI-Public7640142810582
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172315
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 09/30/2020
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 NumberSET ROTAREX®S 6F X 135CM
Device Catalogue Number80237
Device Lot Number200600
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/09/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/30/2020
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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