MAUDE Adverse Event Report: UNKNOWN ROTAREX; THROMBECTOMY & ATHERECTOMY

Catalog Number 80224

Device Problems Overheating of Device (1437); Material Separation (1562); Mechanical Jam (2983); Noise, Audible (3273); Activation Problem (4042)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/10/2021

Event Type  Injury  

Event Description

It was reported that during a recanalization procedure, the abnormal noise was allegedly heard.It was further reported that bleeding was allegedly found and it was treated by open surgery.Current status of the patient is unknown.

Manufacturer Narrative

The catalog number identified in 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.As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.However, an image was provided for review.The investigation of the reported event is currently underway.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.(expiry date: 01/2024).Device pending return.

Manufacturer Narrative

H10: the catalog number identified in section d4 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 d2 and g4.H10: 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.Video and image were provided for review.The catheter ran smoothly and didn't show any malfunction.The required aspiration rate was reached.The user reported a grinding sound, which can also be heard in the attached user video.The heard sound is a normal sound during the intervention and can appear when working in a dense occlusion or when the catheter gets clogged.This is an indicator to slow down the advancing speed of the catheter, while working in dense occlusions the catheter has to be moved back and forth, so a chance is given to transport the thrombotic and calcified material in the collecting bag.Therefore, the investigation is inconclusive for the reported issues.The 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.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: b5, d4 (expiry date: 01/2024), g3.H11: h6 (device, method, result, conclusion).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.

Event Description

It was reported that during a recanalization procedure, the abnormal noise was allegedly heard which recommended to slow down the speed of catheter.The catheter was allegedly separated from the helix.It was further reported that bleeding was allegedly found and it was treated by open surgery.Reportedly, there was no outflow of the liquid from the catheter which leads to over heating of device.Current status of the patient is unknown.

• 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: 12998602
• MDR Text Key: 282190107
• Report Number: 3008439199-2021-00203
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K172315
• 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,Followup
• Report Date: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 80224
• Device Lot Number: 210590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2022
• 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
• Patient Outcome(s): Required Intervention; Other