MAUDE Adverse Event Report: UNKNOWN ROTAREX; THROMBECTOMY & ATHERECTOMY

Catalog Number 80219

Device Problems Material Deformation (2976); Mechanical Jam (2983)

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

Event Date 09/16/2022

Event Type  malfunction  

Event Description

It was reported that during preparation of a recanalization procedure, the guidewire allegedly stuck in the catheter.The procedure was completed using another device.There was no patient contact.

Manufacturer Narrative

The catalog number identified in this report has not been cleared in the us but is similar to the rotarex that are cleared in the us.The pro code and 510 k number for the rotarex are identified in this report.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.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: the sample was returned for evaluation.A physical investigation was performed for the catheter.The catheter had little trace of bodily tissue except material in the handle.During physical investigation was found the tip of the helix was strongly kinked.The guidewire could not advance from the back because of hardened material and no possible to pass the guidewire due to the kink.Moreover the handle of the catheter was blocked with body type material.Therefore, the investigation is confirmed for the reported issues.A definitive root cause could not be determined based upon available information.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 expiry date: 07/2024.

• Brand Name: ROTAREX
• 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: 15957871
• MDR Text Key: 307818234
• Report Number: 3008439199-2022-00179
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K211738
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 80219
• Device Lot Number: 220254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2022
• 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