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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 ROTAREX®S 6F X 135CM
Device Problems Fracture (1260); Obstruction of Flow (2423)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/14/2020
Event Type  malfunction  
Manufacturer Narrative
Evaluation protocol not completed yet.
 
Event Description
During the intervention in the occlusion brakes the fas.Removed the parts with snare.They used a second rotarex with access.
 
Manufacturer Narrative
Translation of evaluation summary report to english.
 
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Brand Name
ROTAREXS 6F 135CM (STRAUB MEDICAL)
Type of Device
ATHERECTOMY CATHETER
Manufacturer (Section D)
STRAUB MEDICAL AG
straubstrasse 12
wangs, sankt gallen 7323
SZ  7323
MDR Report Key10841112
MDR Text Key217693109
Report Number3008439199-2020-00057
Device Sequence Number1
Product Code MCW
UDI-Device Identifier07640142810315
UDI-Public7640142810315
Combination Product (y/n)N
PMA/PMN Number
K172315
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup
Report Date 10/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/07/2023
Device Model NumberROTAREX®S 6F X 135CM
Device Catalogue Number80202
Device Lot Number200543
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/21/2020
Initial Date Manufacturer Received 10/16/2020
Initial Date FDA Received11/14/2020
Supplement Dates Manufacturer Received10/16/2020
Supplement Dates FDA Received12/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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