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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN ROTAREX THROMBECTOMY & ATHERECTOMY

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UNKNOWN ROTAREX THROMBECTOMY & ATHERECTOMY Back to Search Results
Catalog Number 80224
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/15/2021
Event Type  malfunction  
Manufacturer Narrative
The catalog number identified has not been cleared in the us but is similar to the rotarex that are cleared in the us. The pro code and 510 k number for the rotarex are identified. As the lot number for the device was not provided, a review of the device history records could not be performed. The return of the sample is pending. However, photos were provided for review. The investigation of the reported event is currently underway. The medical device manufacturer (d3) and manufacturing location (g1) for the straub product was selected as unknown due to system limitations. The correct medical device manufacturer and manufacturing location are straub medical us. Device pending return.
 
Event Description
It was reported that prior to a recanalization procedure and upon inspection, the device box was allegedly noted to be missing all labels. There was no patient contact.
 
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Brand NameROTAREX
Type of DeviceTHROMBECTOMY & ATHERECTOMY
Manufacturer (Section D)
UNKNOWN
BR
Manufacturer (Section G)
UNKNOWN
BR
Manufacturer Contact
judy ludwig
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key12965901
MDR Text Key281990066
Report Number3008439199-2021-00200
Device Sequence Number1
Product Code MCW
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 Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/16/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number80224
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/19/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/16/2022
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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