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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 Calcium Deposits/Calcification (1758); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/08/2020
Event Type  malfunction  
Manufacturer Narrative
Evaluation protocol not completed yet.
 
Event Description
Sfa cto: cook high flex sheath.Rep concerned about bifurcation, discussed with doc.Straight illiac.Doc did not measure bifurcation.Calcified cto in sfa, changed to retrograde.Ivis confirmed intraluminal.Rep discussed level of calcification and recommended not using rotarex.Used balloon to open it up, 2.5 balloon.Rotarex up and over, going well.Hit calcification and clutched out.Doc pulls back and device broke off.Used snare to retrieve, 100mm of device.Was in contralateral illiac where broke.Device active for about 20 seconds, great flow.Over 5 bd reps in the room.
 
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Brand Name
ROTAREXS 6F 110CM (STRAUB MEDICAL)
Type of Device
ATHERECTOMY CATHETER
Manufacturer (Section D)
STRAUB MEDICAL AG
straubstrasse 12
wangs, sankt gallen 7323
SZ  7323
MDR Report Key10792508
MDR Text Key218718178
Report Number3008439199-2020-00055
Device Sequence Number1
Product Code MCW
UDI-Device Identifier07640142810575
UDI-Public7640142810575
Combination Product (y/n)N
PMA/PMN Number
K172315
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/09/2020
1 Device was Involved in the Event
1 Patient was 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 Health Professional
Device Expiration Date05/26/2023
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
Date Manufacturer Received10/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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