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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ROTAREX THROMBECTOMY & ATHERECTOMY

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BARD PERIPHERAL VASCULAR, INC. ROTAREX THROMBECTOMY & ATHERECTOMY Back to Search Results
Catalog Number 80219
Device Problems Crack (1135); Failure to Infuse (2340)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/03/2021
Event Type  malfunction  
Manufacturer Narrative
The fda rn number and manufacturing location for the straub product was selected as (b)(4) and unknown due to system limitations. The correct fda rn number and manufacturing location are 3008439199 and straub medical us. 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.
 
Event Description
It was reported that during a procedure to treat thrombosis in the sfa and popliteal artery and after aspiration, no blood flow was noted. The device was reported to be withdrawn and no liquid was noted to be flowing out when flushing it. The procedure was completed using another device. There was no reported patient injury.
 
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Brand NameROTAREX
Type of DeviceTHROMBECTOMY & ATHERECTOMY
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
Manufacturer (Section G)
UNKNOWN
BR
Manufacturer Contact
judy ludwig
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key11782651
MDR Text Key249272600
Report Number2020394-2021-00986
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K172315
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number80219
Device Lot Number201288
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/21/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/27/2021
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: 05/06/2021 Patient Sequence Number: 1
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