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

Model Number Version 1.0

Device Problems Device Markings/Labelling Problem (2911); Inaccurate Information (4051)

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

Event Date 10/19/2022

Event Type  malfunction  

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 (b)(4).Manufacturing review: a device history record review was not performed as deviation does not affect the product itself.Investigation summary: the sample was not returned for evaluation and a photo was provided for review.Based on the provided information, the reported issue was confirmed.The definitive root cause traced to labeling.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.Device not returned.

Event Description

It was reported that prior to the recanalization procedure, the device allegedly had an incorrect serial number on the external packaging and did not match the device in the packaging.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: 15850768
• MDR Text Key: 307634935
• Report Number: 3008439199-2022-00170
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 07640142810889
• UDI-Public: (01)07640142810889
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K211738
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2022
• 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