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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 Problem Fracture (1260)
Patient Problems Embolism (1829); Perforation of Vessels (2135); Vascular Dissection (3160); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/20/2020
Event Type  malfunction  
Event Description
On (b)(6) 2020 @ 15. 00 pm. The doctor puncture the female patient in the right of femoral artery and crossover to left sfa lesion in native vessel and injected heparin 5,000 iu. He has used rotarex 6f 110 cm after 2 passed and he pulled it out of the patient and tip of helix stretch out and not back in the catheter. Therefore, the doctor change to rotarex 6f 135 cm after first passed after he pulled it out of the patient and the helix is not inside the catheter.
 
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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 Key9986006
MDR Text Key188533975
Report Number3008439199-2020-00002
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeTH
PMA/PMN Number
K172315
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup,Followup
Report Date 03/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2020
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 Number80208
Device Lot Number191189
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/30/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/23/2020
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

Patient Treatment Data
Date Received: 04/22/2020 Patient Sequence Number: 1
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