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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
Model Number VERSION 1.0
Device Problem Failure to Advance (2524)
Patient Problem Perforation of Vessels (2135)
Event Date 09/27/2021
Event Type  Injury  
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records will be performed. The sample was not returned to the manufacturer for inspection/evaluation. Therefore, the investigation of the reported event is inconclusive. Based upon the available information, the definitive root cause for this event is unknown. The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device. Upon receipt of new or additional information, a follow-up report will be submitted as applicable. The medical device manufacturer and manufacturing location for the straub product was selected as unknown due to system limitations. The correct medical device manufacturer and manufacturing location are straub medical us. (expiry date: 08/2023). Device not returned.
 
Event Description
It was reported that during a procedure, the device allegedly bogged down in the lesion. It was further reported that device allegedly perforated the vessel in the treatment site. Patient current status is unknown.
 
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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 Key12688001
MDR Text Key278078232
Report Number3008439199-2021-00171
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 Other,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberVERSION 1.0
Device Catalogue Number80237
Device Lot Number201155
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/01/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 10/25/2021 Patient Sequence Number: 1
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