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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 ROTAREX®S 8F X 110CM
Device Problems Use of Device Problem (1670); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/24/2020
Event Type  malfunction  
Manufacturer Narrative
Summary evaluation was translated from (b)(6) to english language.
 
Event Description
Long left sfa lesion. Cross over with 8f dura sheath. Treatment with 8f rotarex. When pulling back the rotarex dr. Tessarek noticed that a part of the helix and rotarex head was separated. Separated part was snared into the sheath.
 
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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 Key10770170
MDR Text Key214149304
Report Number3008439199-2020-00052
Device Sequence Number1
Product Code MCW
UDI-Device Identifier07640142810391
UDI-Public7640142810391
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 10/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberROTAREX®S 8F X 110CM
Device Catalogue Number80224
Device Lot Number200790
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/28/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/05/2020
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: 11/02/2020 Patient Sequence Number: 1
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