MAUDE Adverse Event Report: UNKNOWN ROTAREX; THROMBECTOMY & ATHERECTOMY

Model Number Version 1.0

Device Problems Material Deformation (2976); Activation Problem (4042)

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

Event Date 01/05/2022

Event Type  malfunction  

Event Description

It was reported that during a recanalization procedure, the catheter tip and inner helix allegedly stopped spinning.The procedure was completed by using another device.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: a physical investigation was performed for the returned catheter.The catheter showed a damaged tubing 94 cm distal from tip.Further investigation did not show a broken helix but the catheter didn't show any rotation.The activation problem, reported by the user, can be confirmed.A definitive root cause could not be determined based upon the available information.Labeling review: the instruction for use contains instructions to avoid handling errors of the catheter such as kinking outside the patient body.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.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.

• Brand Name: ROTAREX
• Type of Device: THROMBECTOMY & 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 Key: 13965925
• MDR Text Key: 290458838
• Report Number: 3008439199-2022-00034
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 07640142810582
• UDI-Public: (01)07640142810582
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172315
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• 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: 80237
• Device Lot Number: 210163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2022
• 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 Sequence Number: 1