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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRAUB MEDICAL AG ROTAREXS 8F 110CM (STRAUB MEDICAL) ATHERECTOMY CATHETER

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STRAUB MEDICAL AG ROTAREXS 8F 110CM (STRAUB MEDICAL) ATHERECTOMY CATHETER Back to Search Results
Model Number SET ROTAREX®S 8F X 110CM
Device Problems Mechanical Jam (2983); Noise, Audible (3273); Physical Resistance/Sticking (4012)
Patient Problems Perforation of Vessels (2135); Rupture (2208)
Event Date 05/15/2020
Event Type  Injury  
Manufacturer Narrative
Suspect device not returned yet. The return of the suspect device is expected.
 
Event Description
It was realized all the preparation steps before it use. It was used the guide wire 0,018" of the set. The catheter moved to the lesion without any resistance. In the moment of the aspiration, there was a different noise, but the physician continued the aspiration and during if the blood flow to the bag was normally. Before 2 cm to complete the lesion aspiration, the physician noted a vessel rupture, as you can see in the images attached. The time of aspiration was 10 to 15 second until the rupture. The physician removed the catheter and he felt a great resistance. When the catheter was out off the patient, in a attempt to remove the guide wire from the catheter, the physician noted that the guide wire was stuck in the catheter. The vessel rupture was corrected with a balloon and after it was used a coated stent. The patient is doing fine.
 
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Brand NameROTAREXS 8F 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 Key10230946
MDR Text Key197563335
Report Number3008439199-2020-00013
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeBR
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 06/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSET ROTAREX®S 8F X 110CM
Device Catalogue Number80224
Device Lot Number191293
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/20/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/10/2020
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: 07/04/2020 Patient Sequence Number: 1
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