Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 ROTAREXS 6F 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 ROTAREXS 6F 110CM (STRAUB MEDICAL); ATHERECTOMY CATHETER Back to Search Results
Model Number ROTAREX®S 6F X 110CM
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/11/2020
Event Type  malfunction  
Manufacturer Narrative
Summary evaluation was translated from (b)(6) to english language.
 
Event Description
After performing rotarex thrombectomy in the lesion, the head of the catheter was detached from the shaft.The detached catheter could fortunately be removed from the artery back into the sheath without complications.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ROTAREXS 6F 110CM (STRAUB MEDICAL)
Type of Device
ATHERECTOMY 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 Key10958175
MDR Text Key220918554
Report Number3008439199-2020-00064
Device Sequence Number1
Product Code MCW
UDI-Device Identifier07640142810285
UDI-Public7640142810285
Combination Product (y/n)N
Reporter Country CodeGM
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
Report Date 11/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/12/2023
Device Model NumberROTAREX®S 6F X 110CM
Device Catalogue Number80219
Device Lot Number200483
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2020
Date Manufacturer Received11/08/2020
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 Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age73 YR
Patient Weight88
-
-