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U.S. Department of Health and Human Services

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

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STRAUB MEDICAL AG ROTAREX®S 6F 135CM (STRAUB MEDICAL®) ATHERECTOMY CATHETER Back to Search Results
Model Number ROTAREX®S 6F
Device Problem Fracture (1260)
Patient Problems Embolism (1829); Perforation of Vessels (2135); Vascular Dissection (3160)
Event Date 03/17/2020
Event Type  malfunction  
Event Description
Doctor was puncture at r femoral artery to crossover to left femoral artery.  the patient was injected 5,000 iu of haparin as started.  rotarex was used at 1st pass with good flow and good progression then rotarex was used at 2nd passed with flow rate lower than 1st passed. Time were used of each passed approx 1 min with forward and backward as usual.  after 2nd passes doctor was find with rotarex then she planed to do pta so she withdraw the cathter out then she found a helix was broken.
 
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Brand NameROTAREX®S 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 Key9977140
MDR Text Key229479671
Report Number3008439199-2020-00001
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
Report Date 03/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberROTAREX®S 6F
Device Catalogue Number80201
Device Lot Number200016
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 Received03/18/2020
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: 04/20/2020 Patient Sequence Number: 1
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