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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 Problems Loss of or Failure to Bond (1068); Break (1069); Fracture (1260); Device Damaged by Another Device (2915); No Flow (2991)
Patient Problems Thrombosis (2100); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/27/2020
Event Type  malfunction  
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. At the beginning, blood was found flowing out. After around one minute, no blood flow was found. Withdraw the catheter, it was found broken at the head. Pta was used to the patient and complete the operation.
 
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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 Key10016768
MDR Text Key201872286
Report Number3008439199-2020-00005
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
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup,Followup
Report Date 04/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/01/2020
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 Number190857
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/22/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/03/2020
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: 05/01/2020 Patient Sequence Number: 1
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