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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 Entrapment of Device (1212); Fracture (1260); Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Date 09/29/2020
Event Type  Injury  
Manufacturer Narrative
Suspect device not returned yet. The return of suspect device is expected.
 
Event Description
Thrombosis was found in sfa. Anterograde puncture was performed. Straub guildwire was used. Syringe was used to flush the catheter before inserting into the body. Guildwire reached 15cm beyond the thrombosis. Catheter reached 2cm before the thrombosis and started the motor. Aspiration and taking out for flushing. The second time, taking out the catheter and found the head of the catheter left in body. Snare was used to take it out but failed. Open surgery was then conducted to take it out.
 
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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 Key10906682
MDR Text Key218717673
Report Number3008439199-2020-00063
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K172315
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 10/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSET ROTAREX®S 6F X 110CM
Device Catalogue Number80219
Device Lot Number200840
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/15/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/27/2020
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: 11/25/2020 Patient Sequence Number: 1
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