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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 SET ROTAREX®S 6F X 135CM
Device Problems Stretched (1601); Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Vascular Dissection (3160); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/05/2021
Event Type  malfunction  
Manufacturer Narrative
Suspect device not returned yet. The return of suspect device is expected.
 
Event Description
There was a case on (b)(6) 2021, patient was punctured at right femoral artery and crossover to left proximal sfa in stent occlusion and heparin were gaved 5,000 iu as initial and repeat heparin 1,000 iu every hour. Doctor has choose rotarex 6f 135 cm , at first run rotarex ,he felt something not smooth and for second pass seem like catheter could not run passed through the clot. Finally he decided to remove the catheter and find out that tip of the catheter was stretch from catheter. Then change to new catheter , rotarex 6f 135cm with 3 passes and pta balloons. Finally patient got the flow in sfa.
 
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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 Key11633298
MDR Text Key260126495
Report Number3008439199-2021-00028
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 Health Professional,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 03/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSET ROTAREX®S 6F X 135CM
Device Catalogue Number80202
Device Lot Number201295
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/23/2021
Date Manufacturer Received03/11/2021
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

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