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

Model Number VERSION 1.0

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/19/2022

Event Type  malfunction  

Manufacturer Narrative

The medical device manufacturer name,city and state 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.(expiry date: 03/2026).

Event 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.

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.H10: d4 (expiry date: 03/2026).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.

Event 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.

• Brand Name: ROTAREX & ASPIREX DRIVE SYSTEM
• Type of Device: 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: 15389515
• MDR Text Key: 305993213
• Report Number: 3008439199-2022-00132
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 07640142810889
• UDI-Public: (01)07640142810889
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211738
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VERSION 1.0
• Device Catalogue Number: 80300
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/28/2022
• 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: Reuse
• Patient Sequence Number: 1