• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRAUB MEDICAL AG ROTAREX®S 8F 110CM (STRAUB MEDICAL®) ATHERECTOMY CATHETER Back to Search Results
Model Number SET ROTAREX®S 8F X 110CM
Device Problems Break (1069); Fracture (1260); Physical Resistance/Sticking (4012)
Patient Problems Perforation of Vessels (2135); Rupture (2208)
Event Date 03/17/2021
Event Type  Injury  
Manufacturer Narrative
Suspect device not returned yet. The return of suspect device is expected.
 
Event Description
A 6f rotarex s 110cm catheter was being used by doctor for a thrombectomy/atherectomy procedure within the sfa. It was large portion of the vessel being treated in which much of the of it was calcified plaque. The device was working hard to get through the plaque within the sfa. At one point, the guidewire was getting stuck within the catheter and catheter housing itself before the registrar noticed upon pulling out the catheter back that the internal helix had broken and pierced through the catheter itself about half up. A angiograph was then done and it revealed a rupture in the mid sfa. A balloon was then inserted and inflated to see if the vessel would clot enough to close the rupture. After this was done the rupture hadn't completely sealed and a long covered stent was deployed along the sfa. It is our understanding that the patient will be kept in over night for observation. The patient suffered an sfa rupture which meant that a covered stent had to be used which likely wouldn't have used for the procedure.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameROTAREX®S 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 Key11678680
MDR Text Key245816303
Report Number3008439199-2021-00030
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K172315
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 03/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2021
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 Number201554
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/23/2021
Date Manufacturer Received03/19/2021
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: 04/16/2021 Patient Sequence Number: 1
-
-