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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 Break (1069); Fracture (1260)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/08/2020
Event Type  malfunction  
Manufacturer Narrative
Evaluation protocol not completed yet.
 
Event Description
Anastomotic lesion in bypass graft, proximal location. Up and over, not a steep bifurcation. Rotarex clutched out (no calcification in graft, purely intimal hyperplasia). Device kept running, but saw the tip wasn't spinning. Broken helix came out of catheter when being withdrawn from ansel sheath. 100mm length broke. Hi flex cook ansel sheath. Run time about 8 seconds.
 
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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 Key10792735
MDR Text Key216414348
Report Number3008439199-2020-00056
Device Sequence Number1
Product Code MCW
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 10/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/05/2020
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 Number80236
Device Lot Number200704
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/27/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/09/2020
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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