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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRAUB MEDICAL AG ROTAREXS 6F 135CM (STRAUB MEDICAL) ATHERECTOMY CATHETER

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STRAUB MEDICAL AG ROTAREXS 6F 135CM (STRAUB MEDICAL) ATHERECTOMY CATHETER Back to Search Results
Model Number SET ROTAREX®S 6F X 135CM
Device Problems Fracture (1260); Patient-Device Incompatibility (2682)
Patient Problems Embolism (1829); Perforation of Vessels (2135); Vascular Dissection (3160); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/25/2020
Event Type  malfunction  
Manufacturer Narrative
Use of second device during this procedure is described and investigated in 3008439199-2020-00022.
 
Event Description
Gained access on left common fem to treat right sfa. Left common fem was heavily calcified so a short 4mm balloon was used to predilate the cfa in order to insert the sheath. A 6x45 cook ansel was run up and over. Dr. (b)(6) crossed a cto in the distal sfa with a wire/catheter. A 135cm rotarex was then inserted and run down to the distal sfa to treat the lesion that was just crossed. After a minute or so of running, the audible sound from rotarex changed letting us know there was a problem. It was identified that fluid was not being sucked into the collection bag so it was decided to remove the device from the patient. During removal we noticed the cook sheath had prolapsed up into the aorta. I asked dr. (b)(6) if he thought this was a steep bifurcation to which he said no and pulled the sheath back down to show a nice arc shape over the bifurcation. Upon removal the tip of the rotarex was placed in saline to run and it would not aspirate. Use of second device during this procedure is described and investigated in 3008439199-2020-00022.
 
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Brand NameROTAREXS 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 Key10319387
MDR Text Key207417296
Report Number3008439199-2020-00021
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172315
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 06/25/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/24/2020
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 Number80237
Device Lot Number200475
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/29/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/25/2020
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

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