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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN ROTAREX SET 6F 135CM THROMBECTOMY & ATHERECTOMY

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UNKNOWN ROTAREX SET 6F 135CM THROMBECTOMY & ATHERECTOMY Back to Search Results
Catalog Number 80237
Device Problems Detachment of Device or Device Component (2907); Migration (4003)
Patient Problems Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/01/2021
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: 06/2023). The information provided by bd represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
 
Event Description
It was reported that post device placement procedure, the wire was allegedly detached in the artery. It was further reported that the wire was removed through additional surgical procedure. The patient's current status was unknown.
 
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Brand NameROTAREX SET 6F 135CM
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 Key12055859
MDR Text Key258025567
Report Number3008439199-2021-00101
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number80237
Device Lot Number200822
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/12/2021
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: 06/24/2021 Patient Sequence Number: 1
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