MAUDE Adverse Event Report: UNKNOWN ROTAREX & ASPIREX DRIVE SYSTEM; THROMBECTOMY & ATHERECTOMY

Model Number	VERSION 1.0
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.As the serial number for the device was provided, a review of the device history records will be performed.The return of the sample is pending.The investigation of the reported event is currently underway device pending return.
Event or Problem Description
It was reported that prior to a recanalization procedure, the device was packed with external packaging labeled with the incorrect serial number.There was no patient contact.
Event or Problem Description
It was reported that prior to a recanalization procedure, the device was packed with external packaging labeled with the incorrect serial number.There was no patient contact.
Additional Manufacturer Narrative
H10: additional information was received, the convenience sticker is part of the internal process and not related to manufacturing/service labeling issue and hence this record will not be consider as a complaint.However, since an initial mdr was submitted, the file will remain assessed as a malfunction.H10: 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.H11:section a through f - 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.H3 other text : device pending return.

• Brand Name: ROTAREX & ASPIREX DRIVE SYSTEM
• Common Device Name: THROMBECTOMY & ATHERECTOMY
• Manufacturer (Section D): UNKNOWN; BR
• Manufacturer (Section G): UNKNOWN; BR
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15353535
• Report Number: 3008439199-2022-00118
• Device Sequence Number: 6049772
• Product Code: MCW
• UDI-Device Identifier: 07640142810889
• UDI-Public: (01)07640142810889
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K211738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: VERSION 1.0
• Device Catalogue Number: 80300
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2022
• Supplement Date Received by Manufacturer: 09/28/2022
• Initial Report FDA Received Date: 09/03/2022
• Supplement Report FDA Received Date: 10/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown