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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Perforation of Vessels (2135)
Event Date 10/26/2021
Event Type  Injury  
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed. The return of the sample is pending. The investigation of the reported event is currently underway. 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 pending return.
 
Event Description
It was reported that during recanalization procedure, allegedly there was a perforation of the vessel at the distal end of the stent. After performing ballooning procedure and placing a covered stent over the perforated area, the bleeding stopped. The patient status was 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 Key12850949
MDR Text Key281070956
Report Number3008439199-2021-00193
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 02/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2021
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? Device Returned to Manufacturer
Date Returned to Manufacturer02/07/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/17/2022
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

Patient Treatment Data
Date Received: 11/22/2021 Patient Sequence Number: 1
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